Trial Outcomes & Findings for Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC (NCT NCT05239468)
NCT ID: NCT05239468
Last Updated: 2026-07-16
Results Overview
Serum samples were collected at scheduled visits during the double-blind treatment period. Changes in ALP were evaluated using a mixed-effects repeated-measures model (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. Change from Baseline was calculated as post Baseline value minus Baseline value.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2026-07-16
Participant Flow
This was a Phase 2a, double-blind (DB), randomized, active-controlled, parallel group study to evaluate the efficacy, safety and tolerability of Obeticholic Acid (OCA) administered in combination with Bezafibrate (BZF) doses compared to BZF alone in participants with Primary Biliary Cholangitis (PBC). The eligible participants from double-blind phase entered the Long-Term Safety Extension (LTSE) phase.
A total of 72 participants were enrolled into the double-blind phase of the study. 67 participants entered the LTSE phase.
Participant milestones
| Measure |
Placebo + BZF 100 Milligrams (mg)
Participants received BZF 100 mg immediate-release (IR) tablets orally once daily (QD), along with matching placebo tablets for both BZF and OCA to maintain blinding.
|
OCA 5 mg + BZF 100 mg
Participants received OCA 5mg and BZF 100 mg IR tablets orally QD, along with matching placebo BZF tablets to maintain blinding.
|
Placebo + BZF 400 mg
Participants received BZF 400 mg IR tablets orally QD, along with matching placebo OCA tablets to maintain blinding.
|
OCA 5 mg + BZF 400 mg
Participants received OCA 5mg and BZF 400 mg IR tablets orally QD
|
|---|---|---|---|---|
|
DB Period: Up to Week 12
STARTED
|
19
|
16
|
19
|
18
|
|
DB Period: Up to Week 12
COMPLETED
|
17
|
15
|
19
|
16
|
|
DB Period: Up to Week 12
NOT COMPLETED
|
2
|
1
|
0
|
2
|
|
LTSE Period: Week 12 to Week 156
STARTED
|
0
|
0
|
0
|
67
|
|
LTSE Period: Week 12 to Week 156
COMPLETED
|
0
|
0
|
0
|
0
|
|
LTSE Period: Week 12 to Week 156
NOT COMPLETED
|
0
|
0
|
0
|
67
|
Reasons for withdrawal
| Measure |
Placebo + BZF 100 Milligrams (mg)
Participants received BZF 100 mg immediate-release (IR) tablets orally once daily (QD), along with matching placebo tablets for both BZF and OCA to maintain blinding.
|
OCA 5 mg + BZF 100 mg
Participants received OCA 5mg and BZF 100 mg IR tablets orally QD, along with matching placebo BZF tablets to maintain blinding.
|
Placebo + BZF 400 mg
Participants received BZF 400 mg IR tablets orally QD, along with matching placebo OCA tablets to maintain blinding.
|
OCA 5 mg + BZF 400 mg
Participants received OCA 5mg and BZF 400 mg IR tablets orally QD
|
|---|---|---|---|---|
|
DB Period: Up to Week 12
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
|
DB Period: Up to Week 12
Sponsor's Decision
|
0
|
0
|
0
|
1
|
|
DB Period: Up to Week 12
Inclusion/Exclusion Criteria
|
1
|
0
|
0
|
0
|
|
DB Period: Up to Week 12
Participant not eligible for rollover to phase 3
|
0
|
1
|
0
|
0
|
|
LTSE Period: Week 12 to Week 156
Withdrawal by Subject
|
0
|
0
|
0
|
5
|
|
LTSE Period: Week 12 to Week 156
Lost to Follow-up
|
0
|
0
|
0
|
2
|
|
LTSE Period: Week 12 to Week 156
Investigator's Decision
|
0
|
0
|
0
|
6
|
|
LTSE Period: Week 12 to Week 156
Sponsor's Decision
|
0
|
0
|
0
|
2
|
|
LTSE Period: Week 12 to Week 156
Adverse Event
|
0
|
0
|
0
|
2
|
|
LTSE Period: Week 12 to Week 156
Inclusion/Exclusion Criteria
|
0
|
0
|
0
|
2
|
|
LTSE Period: Week 12 to Week 156
Participants rolled over to Phase 3
|
0
|
0
|
0
|
48
|
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 100 mg
n=19 Participants
Participants received BZF 100 mg IR tablets orally QD, along with matching placebo tablets for both BZF and OCA to maintain blinding.
|
OCA 5 mg + BZF 100 mg
n=16 Participants
Participants received OCA 5mg and BZF 100 mg IR tablets orally QD, along with matching placebo BZF tablets to maintain blinding.
|
Placebo + BZF 400 mg
n=19 Participants
Participants received BZF 400 mg IR tablets orally QD, along with matching placebo OCA tablets to maintain blinding.
|
OCA 5 mg + BZF 400 mg
n=18 Participants
Participants received OCA 5mg and BZF 400 mg IR tablets orally QD.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
11 Participants
n=267 Participants
|
8 Participants
n=265 Participants
|
41 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 9.17 • n=9 Participants
|
53.9 years
STANDARD_DEVIATION 12.68 • n=27 Participants
|
57.1 years
STANDARD_DEVIATION 10.74 • n=267 Participants
|
53.3 years
STANDARD_DEVIATION 8.87 • n=265 Participants
|
54.0 years
STANDARD_DEVIATION 10.36 • n=568 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=9 Participants
|
15 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
18 Participants
n=265 Participants
|
68 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
9 Participants
n=265 Participants
|
30 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
|
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)
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
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
17 Participants
n=265 Participants
|
70 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Modified Intent-to-Treat (mITT) Population comprised of all randomized participants who have 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 were evaluated using a mixed-effects repeated-measures model (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. Change from Baseline was calculated as post Baseline value minus Baseline value.
Outcome measures
| Measure |
OCA 5 mg + BZF 100 mg
n=15 Participants
Participants received OCA 5mg and BZF 100 mg IR tablets orally QD, along with matching placebo BZF tablets to maintain blinding.
|
Placebo + BZF 400 mg
n=19 Participants
Participants received BZF 400 mg IR tablets orally QD, along with matching placebo OCA tablets to maintain blinding.
|
OCA 5 mg + BZF 400 mg
n=16 Participants
Participants received OCA 5mg and BZF 400 mg IR tablets orally QD.
|
Placebo + BZF 100 mg
n=17 Participants
Participants received BZF 100 mg IR tablets orally QD, along with matching placebo tablets for both BZF and OCA to maintain blinding.
|
|---|---|---|---|---|
|
Change From Baseline in Alkaline Phosphatase (ALP)
|
-131.9 Units per Liter (U/L)
Standard Error 9.84
|
-163.9 Units per Liter (U/L)
Standard Error 7.01
|
-184.3 Units per Liter (U/L)
Standard Error 7.49
|
-87.2 Units per Liter (U/L)
Standard Error 9.22
|
SECONDARY outcome
Timeframe: At Week 12Population: Intent-to-Treat (ITT) Population comprised of all randomized participants.
Responders were defined as participants achieving a ≥10%, ≥20%, ≥30%, or ≥40% reduction from baseline in serum ALP at week 12 during the DB treatment period with non-responder imputation applied. Baseline ALP was defined as the last evaluations prior to the first administration of investigational product. 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 100 mg
n=16 Participants
Participants received OCA 5mg and BZF 100 mg IR tablets orally QD, along with matching placebo BZF tablets to maintain blinding.
|
Placebo + BZF 400 mg
n=19 Participants
Participants received BZF 400 mg IR tablets orally QD, along with matching placebo OCA tablets to maintain blinding.
|
OCA 5 mg + BZF 400 mg
n=18 Participants
Participants received OCA 5mg and BZF 400 mg IR tablets orally QD.
|
Placebo + BZF 100 mg
n=19 Participants
Participants received BZF 100 mg IR tablets orally QD, along with matching placebo tablets for both BZF and OCA to maintain blinding.
|
|---|---|---|---|---|
|
Percentage of Participants With Response Rates of ≥10%, ≥20%, ≥30% and ≥40% Reduction From Baseline in ALP
≥10% Reduction
|
93.8 percentage of participants
|
100.0 percentage of participants
|
88.9 percentage of participants
|
84.2 percentage of participants
|
|
Percentage of Participants With Response Rates of ≥10%, ≥20%, ≥30% and ≥40% Reduction From Baseline in ALP
≥20% Reduction
|
87.5 percentage of participants
|
100.0 percentage of participants
|
88.9 percentage of participants
|
68.4 percentage of participants
|
|
Percentage of Participants With Response Rates of ≥10%, ≥20%, ≥30% and ≥40% Reduction From Baseline in ALP
≥30% Reduction
|
68.8 percentage of participants
|
94.7 percentage of participants
|
88.9 percentage of participants
|
36.8 percentage of participants
|
|
Percentage of Participants With Response Rates of ≥10%, ≥20%, ≥30% and ≥40% Reduction From Baseline in ALP
≥40% Reduction
|
43.8 percentage of participants
|
89.5 percentage of participants
|
88.9 percentage of participants
|
15.8 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 12Population: ITT Population
Percentage of participants achieving a response in serum ALP at week 12 during the DB treatment period was assessed using non-responder imputation. Analyses of ALP normalization rates were performed using a Cochran-Mantel-Haenszel test stratified by the randomization stratification factor.
Outcome measures
| Measure |
OCA 5 mg + BZF 100 mg
n=16 Participants
Participants received OCA 5mg and BZF 100 mg IR tablets orally QD, along with matching placebo BZF tablets to maintain blinding.
|
Placebo + BZF 400 mg
n=19 Participants
Participants received BZF 400 mg IR tablets orally QD, along with matching placebo OCA tablets to maintain blinding.
|
OCA 5 mg + BZF 400 mg
n=18 Participants
Participants received OCA 5mg and BZF 400 mg IR tablets orally QD.
|
Placebo + BZF 100 mg
n=19 Participants
Participants received BZF 100 mg IR tablets orally QD, along with matching placebo tablets for both BZF and OCA to maintain blinding.
|
|---|---|---|---|---|
|
Normalization Rates of ALP at Week 12
No
|
75.0 percentage of participants
|
57.9 percentage of participants
|
38.9 percentage of participants
|
94.7 percentage of participants
|
|
Normalization Rates of ALP at Week 12
Yes
|
25.0 percentage of participants
|
42.1 percentage of participants
|
61.1 percentage of participants
|
5.3 percentage of participants
|
SECONDARY outcome
Timeframe: At 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 ALP, alanine amino transferase (ALT), aspartate amino transferase (AST), gamma-glutamyl transferase (GGT), total and conjugated bilirubin and lipid panel (cholesterol, high density lipoprotein \[HDL\] and low density lipoprotein \[LDL\]) at Week 12 during the DB treatment period 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 100 mg
n=16 Participants
Participants received OCA 5mg and BZF 100 mg IR tablets orally QD, along with matching placebo BZF tablets to maintain blinding.
|
Placebo + BZF 400 mg
n=19 Participants
Participants received BZF 400 mg IR tablets orally QD, along with matching placebo OCA tablets to maintain blinding.
|
OCA 5 mg + BZF 400 mg
n=18 Participants
Participants received OCA 5mg and BZF 400 mg IR tablets orally QD.
|
Placebo + BZF 100 mg
n=19 Participants
Participants received BZF 100 mg IR tablets orally QD, along with matching placebo tablets for both BZF and OCA to maintain blinding.
|
|---|---|---|---|---|
|
Normalization Rates of Biochemical Disease Markers
AST, Normalization (yes)
|
80.0 percentage of participants
|
68.4 percentage of participants
|
87.5 percentage of participants
|
82.4 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers
ALP, Normalization (yes)
|
25.0 percentage of participants
|
42.1 percentage of participants
|
61.1 percentage of participants
|
5.3 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers
ALP, Normalization (no)
|
75.0 percentage of participants
|
57.9 percentage of participants
|
38.9 percentage of participants
|
94.7 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers
ALT, Normalization (yes)
|
80.0 percentage of participants
|
78.9 percentage of participants
|
100.0 percentage of participants
|
82.4 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers
ALT, Normalization (no)
|
20.0 percentage of participants
|
21.1 percentage of participants
|
0.0 percentage of participants
|
17.6 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers
GGT, Normalization (yes)
|
66.7 percentage of participants
|
42.1 percentage of participants
|
56.3 percentage of participants
|
41.2 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers
GGT, Normalization (no)
|
33.3 percentage of participants
|
57.9 percentage of participants
|
43.8 percentage of participants
|
58.8 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers
AST, Normalization (no)
|
20.0 percentage of participants
|
31.6 percentage of participants
|
12.5 percentage of participants
|
17.6 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers
Total bilirubin, Normalization (yes)
|
86.7 percentage of participants
|
78.9 percentage of participants
|
87.5 percentage of participants
|
88.2 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers
LDL, Normalization (Yes)
|
13.3 percentage of participants
|
15.8 percentage of participants
|
25.0 percentage of participants
|
11.8 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers
Total bilirubin, Normalization (no)
|
13.3 percentage of participants
|
21.1 percentage of participants
|
12.5 percentage of participants
|
11.8 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers
Conjugated bilirubin, Normalization (yes)
|
86.7 percentage of participants
|
83.3 percentage of participants
|
87.5 percentage of participants
|
76.5 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers
Conjugated bilirubin, Normalization (no)
|
13.3 percentage of participants
|
16.7 percentage of participants
|
12.5 percentage of participants
|
23.5 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers
Cholesterol, Normalization (Yes)
|
40.0 percentage of participants
|
31.6 percentage of participants
|
43.8 percentage of participants
|
11.8 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers
Cholesterol, Normalization (No)
|
60.0 percentage of participants
|
68.4 percentage of participants
|
56.3 percentage of participants
|
88.2 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers
HDL, Normalization (Yes)
|
93.3 percentage of participants
|
94.7 percentage of participants
|
87.5 percentage of participants
|
100.0 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers
HDL, Normalization (No)
|
6.7 percentage of participants
|
5.3 percentage of participants
|
12.5 percentage of participants
|
0.0 percentage of participants
|
|
Normalization Rates of Biochemical Disease Markers
LDL, Normalization (No)
|
86.7 percentage of participants
|
84.2 percentage of participants
|
75.0 percentage of participants
|
88.2 percentage of participants
|
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 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. Change from baseline was calculated as post Baseline value minus Baseline value.
Outcome measures
| Measure |
OCA 5 mg + BZF 100 mg
n=15 Participants
Participants received OCA 5mg and BZF 100 mg IR tablets orally QD, along with matching placebo BZF tablets to maintain blinding.
|
Placebo + BZF 400 mg
n=19 Participants
Participants received BZF 400 mg IR tablets orally QD, along with matching placebo OCA tablets to maintain blinding.
|
OCA 5 mg + BZF 400 mg
n=16 Participants
Participants received OCA 5mg and BZF 400 mg IR tablets orally QD.
|
Placebo + BZF 100 mg
n=17 Participants
Participants received BZF 100 mg IR tablets orally QD, along with matching placebo tablets for both BZF and OCA to maintain blinding.
|
|---|---|---|---|---|
|
Change From Baseline in in GGT, ALT and AST Levels
GGT
|
-111.38 International units per Liter (IU/L)
Standard Error 12.138
|
-118.45 International units per Liter (IU/L)
Standard Error 11.425
|
-174.76 International units per Liter (IU/L)
Standard Error 12.251
|
-51.06 International units per Liter (IU/L)
Standard Error 11.370
|
|
Change From Baseline in in GGT, ALT and AST Levels
ALT
|
-14.7 International units per Liter (IU/L)
Standard Error 3.66
|
-13.7 International units per Liter (IU/L)
Standard Error 4.15
|
-21.1 International units per Liter (IU/L)
Standard Error 4.51
|
-7.1 International units per Liter (IU/L)
Standard Error 3.43
|
|
Change From Baseline in in GGT, ALT and AST Levels
AST
|
-8.2 International units per Liter (IU/L)
Standard Error 2.62
|
-5.4 International units per Liter (IU/L)
Standard Error 2.58
|
-10.4 International units per Liter (IU/L)
Standard Error 2.81
|
-2.4 International units per Liter (IU/L)
Standard Error 2.47
|
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. Change from baseline was calculated as post Baseline value minus Baseline value.
Outcome measures
| Measure |
OCA 5 mg + BZF 100 mg
n=15 Participants
Participants received OCA 5mg and BZF 100 mg IR tablets orally QD, along with matching placebo BZF tablets to maintain blinding.
|
Placebo + BZF 400 mg
n=19 Participants
Participants received BZF 400 mg IR tablets orally QD, along with matching placebo OCA tablets to maintain blinding.
|
OCA 5 mg + BZF 400 mg
n=16 Participants
Participants received OCA 5mg and BZF 400 mg IR tablets orally QD.
|
Placebo + BZF 100 mg
n=17 Participants
Participants received BZF 100 mg IR tablets orally QD, along with matching placebo tablets for both BZF and OCA to maintain blinding.
|
|---|---|---|---|---|
|
Change From Baseline in Total and Conjugated Bilirubin
Total Bilirubin
|
-2.133 micromoles per Liter (µmol/L)
Standard Error 0.500
|
-0.860 micromoles per Liter (µmol/L)
Standard Error 0.967
|
-2.867 micromoles per Liter (µmol/L)
Standard Error 1.041
|
-1.397 micromoles per Liter (µmol/L)
Standard Error 0.467
|
|
Change From Baseline in Total and Conjugated Bilirubin
Conjugated Bilirubin
|
-0.299 micromoles per Liter (µmol/L)
Standard Error 0.231
|
0.665 micromoles per Liter (µmol/L)
Standard Error 0.798
|
-1.394 micromoles per Liter (µmol/L)
Standard Error 0.846
|
0.164 micromoles per Liter (µmol/L)
Standard Error 0.216
|
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. Change from baseline was calculated as post Baseline value minus Baseline value.
Outcome measures
| Measure |
OCA 5 mg + BZF 100 mg
n=15 Participants
Participants received OCA 5mg and BZF 100 mg IR tablets orally QD, along with matching placebo BZF tablets to maintain blinding.
|
Placebo + BZF 400 mg
n=19 Participants
Participants received BZF 400 mg IR tablets orally QD, along with matching placebo OCA tablets to maintain blinding.
|
OCA 5 mg + BZF 400 mg
n=16 Participants
Participants received OCA 5mg and BZF 400 mg IR tablets orally QD.
|
Placebo + BZF 100 mg
n=17 Participants
Participants received BZF 100 mg IR tablets orally QD, along with matching placebo tablets for both BZF and OCA to maintain blinding.
|
|---|---|---|---|---|
|
Change From Baseline in Lipid Panel
Total Cholesterol
|
-0.929 millimoles per Liter (mmol/L)
Standard Error 0.237
|
-0.461 millimoles per Liter (mmol/L)
Standard Error 0.184
|
-0.560 millimoles per Liter (mmol/L)
Standard Error 0.198
|
-0.072 millimoles per Liter (mmol/L)
Standard Error 0.218
|
|
Change From Baseline in Lipid Panel
HDL
|
-0.245 millimoles per Liter (mmol/L)
Standard Error 0.078
|
0.028 millimoles per Liter (mmol/L)
Standard Error 0.074
|
-0.240 millimoles per Liter (mmol/L)
Standard Error 0.080
|
0.053 millimoles per Liter (mmol/L)
Standard Error 0.073
|
|
Change From Baseline in Lipid Panel
LDL
|
-0.515 millimoles per Liter (mmol/L)
Standard Error 0.169
|
-0.441 millimoles per Liter (mmol/L)
Standard Error 0.139
|
-0.344 millimoles per Liter (mmol/L)
Standard Error 0.150
|
-0.191 millimoles per Liter (mmol/L)
Standard Error 0.157
|
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 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 post Baseline value minus Baseline value.
Outcome measures
| Measure |
OCA 5 mg + BZF 100 mg
n=15 Participants
Participants received OCA 5mg and BZF 100 mg IR tablets orally QD, along with matching placebo BZF tablets to maintain blinding.
|
Placebo + BZF 400 mg
n=19 Participants
Participants received BZF 400 mg IR tablets orally QD, along with matching placebo OCA tablets to maintain blinding.
|
OCA 5 mg + BZF 400 mg
n=16 Participants
Participants received OCA 5mg and BZF 400 mg IR tablets orally QD.
|
Placebo + BZF 100 mg
n=17 Participants
Participants received BZF 100 mg IR tablets orally QD, along with matching placebo tablets for both BZF and OCA to maintain blinding.
|
|---|---|---|---|---|
|
Change From Baseline of the Plasma Value of 7 Alpha (α) Hydroxy 4 Cholesten-3 One (C4)
|
-10.421 moles per liter (mol/L)
Standard Deviation 13.779
|
-8.378 moles per liter (mol/L)
Standard Deviation 10.479
|
-15.549 moles per liter (mol/L)
Standard Deviation 18.026
|
-0.534 moles per liter (mol/L)
Standard Deviation 16.078
|
SECONDARY outcome
Timeframe: At Week 12Population: ITT Population
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.
Outcome measures
| Measure |
OCA 5 mg + BZF 100 mg
n=16 Participants
Participants received OCA 5mg and BZF 100 mg IR tablets orally QD, along with matching placebo BZF tablets to maintain blinding.
|
Placebo + BZF 400 mg
n=19 Participants
Participants received BZF 400 mg IR tablets orally QD, along with matching placebo OCA tablets to maintain blinding.
|
OCA 5 mg + BZF 400 mg
n=18 Participants
Participants received OCA 5mg and BZF 400 mg IR tablets orally QD.
|
Placebo + BZF 100 mg
n=19 Participants
Participants received BZF 100 mg IR tablets orally QD, along with matching placebo tablets for both BZF and OCA to maintain blinding.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in Bile Acids
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
DB Period: Placebo + BZF 100 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
DB Period: OCA 5 mg + BZF 100 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
DB Period: Placebo + BZF 400 mg
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
DB Period: OCA 5 mg + BZF 400 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
LTSE Period: OCA 5 mg + BZF 400 mg
Serious events: 4 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB Period: Placebo + BZF 100 mg
n=19 participants at risk
Participants received BZF 100 mg IR tablets orally QD, along with matching placebo tablets for both BZF and OCA to maintain blinding.
|
DB Period: OCA 5 mg + BZF 100 mg
n=16 participants at risk
Participants received OCA 5mg and BZF 100 mg IR tablets orally QD, along with matching placebo BZF tablets to maintain blinding.
|
DB Period: Placebo + BZF 400 mg
n=19 participants at risk
Participants received BZF 400 mg IR tablets orally QD, along with matching placebo OCA tablets to maintain blinding.
|
DB Period: OCA 5 mg + BZF 400 mg
n=18 participants at risk
Participants received OCA 5mg and BZF 400 mg IR tablets orally QD.
|
LTSE Period: OCA 5 mg + BZF 400 mg
n=67 participants at risk
Participants received OCA 5mg and BZF 400 mg IR tablets orally QD.
|
|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
General disorders
Pyrexia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
Other adverse events
| Measure |
DB Period: Placebo + BZF 100 mg
n=19 participants at risk
Participants received BZF 100 mg IR tablets orally QD, along with matching placebo tablets for both BZF and OCA to maintain blinding.
|
DB Period: OCA 5 mg + BZF 100 mg
n=16 participants at risk
Participants received OCA 5mg and BZF 100 mg IR tablets orally QD, along with matching placebo BZF tablets to maintain blinding.
|
DB Period: Placebo + BZF 400 mg
n=19 participants at risk
Participants received BZF 400 mg IR tablets orally QD, along with matching placebo OCA tablets to maintain blinding.
|
DB Period: OCA 5 mg + BZF 400 mg
n=18 participants at risk
Participants received OCA 5mg and BZF 400 mg IR tablets orally QD.
|
LTSE Period: OCA 5 mg + BZF 400 mg
n=67 participants at risk
Participants received OCA 5mg and BZF 400 mg IR tablets orally QD.
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
11.1%
2/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
11.1%
2/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.8%
3/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
31.2%
5/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
31.6%
6/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
44.4%
8/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
29.9%
20/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
12.5%
2/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
10.5%
2/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
11.1%
2/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
6.0%
4/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
12.5%
2/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
4.5%
3/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
11.1%
2/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
7.5%
5/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
10.5%
2/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Nervous system disorders
Headache
|
10.5%
2/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
10.5%
2/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
14.9%
10/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
General disorders
Asthenia
|
10.5%
2/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
6.2%
1/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
General disorders
Fatigue
|
10.5%
2/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
7.5%
5/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.5%
2/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
9.0%
6/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
6.2%
1/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
17.9%
12/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
COVID-19
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
10.4%
7/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
4.5%
3/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Influenza
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
7.5%
5/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
11.9%
8/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
4.5%
3/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Tooth Infection
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
4.5%
3/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
10.4%
7/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
4.5%
3/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
9.0%
6/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
7.5%
5/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
4.5%
3/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
4.5%
3/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
Protein urine present
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
9.0%
6/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
4.5%
3/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
6.2%
1/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
10.4%
7/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
13.4%
9/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
10.4%
7/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
4.5%
3/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
6.0%
4/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
6.0%
4/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
7.5%
5/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
General disorders
Pyrexia
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
6.0%
4/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
4.5%
3/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Eye disorders
Dry eye
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
4.5%
3/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
6.2%
1/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
6.0%
4/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
6.2%
1/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
6.2%
1/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Infection
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
6.2%
1/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
Body temperature increased
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
Blood glucose increased
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
Blood pressure increased
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
Mammogram abnormal
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Renal and urinary disorders
Microalbuminuria
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
General disorders
Pain
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
General disorders
Cyst
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
General disorders
Feeling hot
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
General disorders
Oedema peripheral
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
6.2%
1/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
General disorders
Peripheral swelling
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Psychiatric disorders
Depression
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
6.2%
1/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Social circumstances
Menopause
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Vascular disorders
Hypotension
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.6%
1/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Vascular disorders
Hypertension
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
7.5%
5/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Vascular disorders
Superficial vein thrombosis
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Eye disorders
Inflammation of lacrimal passage
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Eye disorders
Periorbital swelling
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
5.3%
1/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Candida infection
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Device related infection
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Ear infection
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Eye infection
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Secondary syphilis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Viral infection
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Noninfective sialoadenitis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
Crystal urine present
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
ECG signs of myocardial ischaemia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
Platelet count increased
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
Blood glucose abnormal
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
Blood urine present
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
Gamma-glutamyl transferase increased
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Investigations
Tri-iodothyronine increased
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Metabolism and nutrition disorders
Impaired fasting glucose
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Spinal retrolisthesis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
4.5%
3/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Renal and urinary disorders
Costovertebral angle tenderness
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
4.5%
3/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
General disorders
Chest discomfort
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
General disorders
Chest pain
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
4.5%
3/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
General disorders
Early satiety
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Nervous system disorders
Tremor
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
4.5%
3/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Reproductive system and breast disorders
Breast disorder
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
3.0%
2/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/16 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/19 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
0.00%
0/18 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
1.5%
1/67 • Up to Week 12 for DB period and Up to Week 156 for LTSE period
Serious TEAEs and TEAEs were collected in safety population and LTSE Population, which comprised of all randomized participants who received at least 1 dose of OCA and/or BZF.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place