Trial Outcomes & Findings for To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate (NCT NCT06488911)
NCT ID: NCT06488911
Last Updated: 2026-06-08
Results Overview
A TEAE was defined as any event not present before the initiation of the investigational product in this study or any event already present, which worsened in either severity or frequency following exposure to the investigational product in this study. A serious TEAE was defined as any untoward medical occurrence that at any dose resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality or birth defect, an important medical event that may jeopardize the participant or may require medical intervention.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
62 participants
Primary outcome timeframe
Early Termination (Up to Month 12)
Results posted on
2026-06-08
Participant Flow
This was a Phase 3, open-label, long-term safety extension (LTSE) that evaluated the safety and tolerability of the fixed-dose combination (FDC) of obeticholic acid (OCA) and bezafibrate (BZF) in participants with primary biliary cholangitis (PBD) for up to 60 months. All participants from Studies 747-213 (NCT04594694) or 747-214 (NCT05239468) who met respective protocol requirements were transitioned into Study 977-311 at their respective sites.
62 total participants were enrolled.
Participant milestones
| Measure |
OCA 5 mg + BZF 400 mg
Participants received FDC tablet (OCA 5mg \[milligrams\] + BZF 400 mg sustained release \[SR\]) once daily (QD).
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
62
|
Reasons for withdrawal
| Measure |
OCA 5 mg + BZF 400 mg
Participants received FDC tablet (OCA 5mg \[milligrams\] + BZF 400 mg sustained release \[SR\]) once daily (QD).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Sponsor Decision
|
60
|
|
Overall Study
Non-compliance with the Protocol
|
1
|
Baseline Characteristics
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
Baseline characteristics by cohort
| Measure |
OCA 5 mg + BZF 400 mg
n=62 Participants
Participants received FDC tablet \[OCA 5mg + BZF 400 mg SR\] QD.
|
|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 9.93 • n=9 Participants
|
|
Sex/Gender, Customized
Male
|
5 participants
n=9 Participants
|
|
Sex/Gender, Customized
Female
|
54 participants
n=9 Participants
|
|
Sex/Gender, Customized
Unknown
|
3 participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Early Termination (Up to Month 12)Population: LTSE Population
A TEAE was defined as any event not present before the initiation of the investigational product in this study or any event already present, which worsened in either severity or frequency following exposure to the investigational product in this study. A serious TEAE was defined as any untoward medical occurrence that at any dose resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality or birth defect, an important medical event that may jeopardize the participant or may require medical intervention.
Outcome measures
| Measure |
OCA 5 mg + BZF 400 mg
n=62 Participants
Participants received FDC tablet \[OCA 5mg + BZF 400 mg SR\] QD.
|
|---|---|
|
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Discontinuation
TEAEs
|
29 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Discontinuation
Serious TEAEs
|
3 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Discontinuation
TEAEs leading to discontinuation
|
1 Participants
|
PRIMARY outcome
Timeframe: Early Termination (Up to Month 12)Population: LTSE Population
A severe (Grade 3) TEAE is defined as an AE that causes inability to carry out usual activities; the subject may experience intolerable discomfort or pain.
Outcome measures
| Measure |
OCA 5 mg + BZF 400 mg
n=62 Participants
Participants received FDC tablet \[OCA 5mg + BZF 400 mg SR\] QD.
|
|---|---|
|
Number of Participants Reporting Severe TEAEs
|
1 participants
|
SECONDARY outcome
Timeframe: Early Termination (Up to Month 12)Population: LTSE Population
All-cause mortality included all reported deaths of participants during the study due to any cause.
Outcome measures
| Measure |
OCA 5 mg + BZF 400 mg
n=62 Participants
Participants received FDC tablet \[OCA 5mg + BZF 400 mg SR\] QD.
|
|---|---|
|
Number of Participants Reporting All-Cause Mortality
|
0 Participants
|
SECONDARY outcome
Timeframe: Early Termination (Up to Month 12)Population: LTSE Population. Only those participants with data available at specified time points have been presented.
Clinically notable shift from baseline in blood hematology parameters data was presented for low and high numbers of participants at early termination visit (up to Month 12). The number of participants with clinically notable shift from baseline was presented.
Outcome measures
| Measure |
OCA 5 mg + BZF 400 mg
n=51 Participants
Participants received FDC tablet \[OCA 5mg + BZF 400 mg SR\] QD.
|
|---|---|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Hemoglobin (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Neutrophils (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Basophils (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Basophils (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Eosinophils (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Eosinophils (High)
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Erythrocyte Mean Corpuscular Hemoglobin Concentration (Low)
|
15 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Erythrocyte Mean Corpuscular Hemoglobin Concentration (High):
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Erythrocyte Mean Corpuscular Hemoglobin (Low)
|
4 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Erythrocyte Mean Corpuscular Hemoglobin (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Erythrocyte Mean Corpuscular Volume (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Erythrocyte Mean Corpuscular Volume (High)
|
4 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Erythrocytes (Low)
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Erythrocytes (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Hematocrit (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Hematocrit (High)
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Hemoglobin (Low)
|
3 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Leukocytes (Low)
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Leukocytes (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Lymphocytes (Low)
|
3 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Lymphocytes (High)
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Monocytes (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Monocytes (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Neutrophils (Low)
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Platelets (Low)
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Platelets (High)
|
4 Participants
|
SECONDARY outcome
Timeframe: Early Termination (Up to Month 12)Population: LTSE Population. Only those participants with data available at specified time points have been presented.
Clinically notable shift from baseline in blood serum chemistry data were presented for low and high numbers of participants at early termination visit (up to Month 12). Change from baseline was calculated as post baseline value minus baseline value. Baseline was defined as the last assessment performed before the first dose of investigational product in Study 977-311.
Outcome measures
| Measure |
OCA 5 mg + BZF 400 mg
n=55 Participants
Participants received FDC tablet \[OCA 5mg + BZF 400 mg SR\] QD.
|
|---|---|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Aspartate Aminotransferase (High)
|
8 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Bicarbonate (Low)
|
15 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Protein (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Albumin (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Albumin (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Alkaline Phosphatase (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Alkaline Phosphatase (High)
|
36 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Alanine Aminotransferase (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Alanine Aminotransferase (High)
|
9 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Amylase (Low)
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Amylase (High)
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Aspartate Aminotransferase (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Bicarbonate (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Direct Bilirubin (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Direct Bilirubin (High)
|
3 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Bilirubin (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Bilirubin (High)
|
7 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Indirect Bilirubin (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Indirect Bilirubin (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Calcium (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Calcium (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Cholesterol (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Cholesterol (High)
|
38 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Creatine Kinase (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Creatine Kinase (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Chloride (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Chloride (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Creatinine (Low)
|
8 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Creatinine (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Free Fatty Acid (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Free Fatty Acid (High)
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Glomerular Filtration Rate, Estimated (Low)
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Glomerular Filtration Rate, Estimated (High)
|
5 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Gamma Glutamyl Transferase (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Gamma Glutamyl Transferase (High)
|
31 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Non-Fasting Glucose (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Non-Fasting Glucose (High)
|
13 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
High Density Cholesterol (Low)
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
High Density Cholesterol (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Hyaluronic Acid (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Hyaluronic Acid (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Potassium (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Potassium (High)
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Low Density Cholesterol (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Low Density Cholesterol (High)
|
37 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Lipase (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Lipase (High)
|
3 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Liver Fibrosis Score (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Liver Fibrosis Score (High)
|
12 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Magnesium (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Magnesium (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Choriogonadotropin Beta (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Choriogonadotropin Beta (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Phosphate (Low)
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Phosphate (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Procollagen 3 N-Terminal Peptide (Low)
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Procollagen 3 N-Terminal Peptide (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Protein (High)
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Sodium (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Sodium (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Tissue Inhibitor of Matrix Metalloproteinase 1 (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Tissue Inhibitor of Matrix Metalloproteinase 1 (High)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Triglycerides (Low)
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Triglycerides (High)
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Urea Nitrogen (Low)
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Urea Nitrogen (High)
|
8 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Very Low-Density Lipoprotein Cholesterol (Low)
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Very Low-Density Lipoprotein Cholesterol (High)
|
1 Participants
|
Adverse Events
OCA 5 mg + BZF 400 mg
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OCA 5 mg + BZF 400 mg
n=62 participants at risk
Participants received FDC tablet \[OCA 5mg + BZF 400 mg SR\] QD.
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
Other adverse events
| Measure |
OCA 5 mg + BZF 400 mg
n=62 participants at risk
Participants received FDC tablet \[OCA 5mg + BZF 400 mg SR\] QD.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rosacea
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
3.2%
2/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.1%
5/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Infections and infestations
Urinary tract infection
|
6.5%
4/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
2/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Infections and infestations
Bronchitis
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Infections and infestations
Influenza
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Infections and infestations
Sinusitis
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Injury, poisoning and procedural complications
Shoulder fracture
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
3.2%
2/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Investigations
Blood alkaline phosphatase increased
|
3.2%
2/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Investigations
Alanine aminotransferase increased
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Investigations
Aspartate aminotransferase increased
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Investigations
Platelet count decreased
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Gastrointestinal disorders
Dental caries
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Cardiac disorders
Palpitations
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
General disorders
Fatigue
|
3.2%
2/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
General disorders
Peripheral swelling
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Reproductive system and breast disorders
Testicular retraction
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
|
Nervous system disorders
Headache
|
1.6%
1/62 • Early Termination (Up to Month 12)
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected in LTSE Population which comprised all participants who received at least 1 dose of the FDC tablet in Study 977-311.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place