Trial Outcomes & Findings for Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis (NCT NCT03517540)
NCT ID: NCT03517540
Last Updated: 2022-04-29
Results Overview
Occurrence of adverse events and serious adverse events Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and then up to 66 weeks
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
193 participants
Primary outcome timeframe
AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Results posted on
2022-04-29
Participant Flow
193 participants enrolled at 65 sites in 17 countries
450 of 643 subjects discontinued during screening phase
Participant milestones
| Measure |
Arm A: Tropifexor (LJN452) - Dose 1
tropifexor 140 mg, once daily
|
Arm B: Cenicriviroc (CVC)
CVC 150 mg, once daily
|
Arm C: Tropifexor (LJN452) Dose 1 + CVC
tropifexor 140 mg + CVC 150 mg, once daily
|
Arm D: Tropifexor Dose 2 + CVC
tropifexor 90 mg + CVC 150 mg, once daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
48
|
47
|
48
|
|
Overall Study
COMPLETED
|
36
|
41
|
38
|
43
|
|
Overall Study
NOT COMPLETED
|
14
|
7
|
9
|
5
|
Reasons for withdrawal
| Measure |
Arm A: Tropifexor (LJN452) - Dose 1
tropifexor 140 mg, once daily
|
Arm B: Cenicriviroc (CVC)
CVC 150 mg, once daily
|
Arm C: Tropifexor (LJN452) Dose 1 + CVC
tropifexor 140 mg + CVC 150 mg, once daily
|
Arm D: Tropifexor Dose 2 + CVC
tropifexor 90 mg + CVC 150 mg, once daily
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
9
|
3
|
8
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
1
|
3
|
Baseline Characteristics
Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis
Baseline characteristics by cohort
| Measure |
Arm A: Tropifexor (LJN452) - Dose 1
n=50 Participants
tropifexor 140 mg, once daily
|
Arm B: Cenicriviroc (CVC)
n=48 Participants
CVC 150 mg, once daily
|
Arm C: Tropifexor (LJN452) Dose 1 + CVC
n=47 Participants
tropifexor 140 mg + CVC 150 mg, once daily
|
Arm D: Tropifexor Dose 2 + CVC
n=48 Participants
tropifexor 90 mg + CVC 150 mg, once daily
|
Total
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 13.35 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 11.79 • n=7 Participants
|
54.7 years
STANDARD_DEVIATION 12.65 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 12.29 • n=4 Participants
|
54.5 years
STANDARD_DEVIATION 12.52 • n=21 Participants
|
|
Age, Customized
<65
|
35 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
149 Participants
n=21 Participants
|
|
Age, Customized
>=65
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Male
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Female
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
41 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
168 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeksPopulation: Safety set (SAF) - All patients who received at least one dose of study drug and had at least one post-baseline safety assessment. Of note, the statement that a patient had no AEs also constituted a safety assessment. Patients were analyzed according to the treatment received
Occurrence of adverse events and serious adverse events Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and then up to 66 weeks
Outcome measures
| Measure |
Arm A: Tropifexor (LJN452) - Dose 1
n=50 Participants
tropifexor 140 mg, once daily
|
Arm B: Cenicriviroc (CVC)
n=48 Participants
CVC 150 mg, once daily
|
Arm C: Tropifexor (LJN452) Dose 1 + CVC
n=47 Participants
tropifexor 140 mg + CVC 150 mg, once daily
|
Arm D: Tropifexor Dose 2 + CVC
n=48 Participants
tropifexor 90 mg + CVC 150 mg, once daily
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Number of participants with at least one Adverse Event (AE)
|
42 Participants
|
41 Participants
|
40 Participants
|
42 Participants
|
|
Number of Participants With Adverse Events
Number of participants with at least one Serious Adverse Events (SAEs)
|
5 Participants
|
3 Participants
|
4 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: baseline to 48 WeeksPopulation: Full analysis set (FAS) - All participants to whom study treatment was assigned (excluding patients who were mis-randomized and did not take investigational drug. Mis-randomized participants were those who were not qualified for randomization but were inadvertently randomized into the study). Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at randomization.
Efficacy of tropifexor + CVC in patients with Nonalcoholic steatohepatitis (NASH) with fibrosis stage F2/F3 as assessed by histological improvement after 48 weeks of treatment compared to monotherapies (tropifexor and CVC) compared to baseline biopsy
Outcome measures
| Measure |
Arm A: Tropifexor (LJN452) - Dose 1
n=31 Participants
tropifexor 140 mg, once daily
|
Arm B: Cenicriviroc (CVC)
n=38 Participants
CVC 150 mg, once daily
|
Arm C: Tropifexor (LJN452) Dose 1 + CVC
n=37 Participants
tropifexor 140 mg + CVC 150 mg, once daily
|
Arm D: Tropifexor Dose 2 + CVC
n=40 Participants
tropifexor 90 mg + CVC 150 mg, once daily
|
|---|---|---|---|---|
|
Proportion of Participants Who Have at Least a One Point Improvement in Fibrosis
|
10 Participants
|
12 Participants
|
11 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: baseline to 48 weeksPopulation: Full analysis set (FAS) - All participants to whom study treatment was assigned (excluding patients who were mis-randomized and did not take investigational drug. Mis-randomized participants were those who were not qualified for randomization but were inadvertently randomized into the study). Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at randomization.
Efficacy of tropifexor + CVC in patients with Nonalcoholic steatohepatitis (NASH) with fibrosis stage F2/F3 as assessed by histological improvement after 48 weeks of treatment compared to monotherapies (tropifexor and CVC) compared to baseline biopsy
Outcome measures
| Measure |
Arm A: Tropifexor (LJN452) - Dose 1
n=31 Participants
tropifexor 140 mg, once daily
|
Arm B: Cenicriviroc (CVC)
n=38 Participants
CVC 150 mg, once daily
|
Arm C: Tropifexor (LJN452) Dose 1 + CVC
n=37 Participants
tropifexor 140 mg + CVC 150 mg, once daily
|
Arm D: Tropifexor Dose 2 + CVC
n=40 Participants
tropifexor 90 mg + CVC 150 mg, once daily
|
|---|---|---|---|---|
|
Proportion of Participants With Resolution of Steatohepatitis
|
8 Participants
|
8 Participants
|
5 Participants
|
9 Participants
|
Adverse Events
Tropifexor 140mg
Serious events: 5 serious events
Other events: 39 other events
Deaths: 0 deaths
CVC 150mg
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Tropifexor 140mcg + CVC 150mg
Serious events: 4 serious events
Other events: 33 other events
Deaths: 0 deaths
Tropifexor 90 mg + CVC 150 mg
Serious events: 10 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tropifexor 140mg
n=50 participants at risk
Tropifexor 140mg
|
CVC 150mg
n=48 participants at risk
CVC 150mg
|
Tropifexor 140mcg + CVC 150mg
n=47 participants at risk
Tropifexor 140mg + CVC 150mg
|
Tropifexor 90 mg + CVC 150 mg
n=48 participants at risk
Tropifexor 90 mg + CVC 150 mg
|
|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Gastrointestinal disorders
Duodenal ulcer
|
2.0%
1/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
1/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
2.0%
1/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
General disorders
Non-cardiac chest pain
|
2.0%
1/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Hepatobiliary disorders
Gallbladder polyp
|
2.0%
1/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Infections and infestations
COVID-19
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
4.2%
2/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Infections and infestations
COVID-19 pneumonia
|
2.0%
1/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Injury, poisoning and procedural complications
Anaesthetic complication
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Metabolism and nutrition disorders
Euglycaemic diabetic ketoacidosis
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
2.0%
1/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
2.0%
1/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
Other adverse events
| Measure |
Tropifexor 140mg
n=50 participants at risk
Tropifexor 140mg
|
CVC 150mg
n=48 participants at risk
CVC 150mg
|
Tropifexor 140mcg + CVC 150mg
n=47 participants at risk
Tropifexor 140mg + CVC 150mg
|
Tropifexor 90 mg + CVC 150 mg
n=48 participants at risk
Tropifexor 90 mg + CVC 150 mg
|
|---|---|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.2%
3/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
4.0%
2/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.2%
3/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
8.3%
4/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
5/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.2%
3/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
10.6%
5/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
4.2%
2/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.0%
3/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
4.2%
2/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
10.6%
5/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
4.2%
2/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Gastrointestinal disorders
Constipation
|
10.0%
5/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
4.2%
2/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
12.8%
6/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.2%
3/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
2/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
14.6%
7/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
8.5%
4/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
1/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.4%
3/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
4.2%
2/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
1/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.4%
3/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
4.2%
2/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.0%
2/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
12.5%
6/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
14.9%
7/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
12.5%
6/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
General disorders
Asthenia
|
8.0%
4/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
4.2%
2/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
10.6%
5/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.2%
3/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
General disorders
Fatigue
|
14.0%
7/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
8.3%
4/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
10.6%
5/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
8.3%
4/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
8.3%
4/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Infections and infestations
Bronchitis
|
2.0%
1/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.4%
3/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Infections and infestations
Ear infection
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.4%
3/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.4%
3/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.2%
3/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
2/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.2%
3/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
4.3%
2/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
4.2%
2/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Infections and infestations
Sinusitis
|
4.0%
2/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
8.5%
4/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.2%
3/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
3/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
4.2%
2/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
10.6%
5/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
10.4%
5/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Infections and infestations
Urinary tract infection
|
14.0%
7/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.2%
3/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
4.3%
2/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
8.3%
4/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
4.0%
2/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.2%
3/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
6.0%
3/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.0%
6/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.2%
3/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
12.8%
6/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.2%
3/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
10.6%
5/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
8.3%
4/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.0%
1/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
4.2%
2/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.4%
3/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
1/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.4%
3/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.2%
3/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
0.00%
0/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Nervous system disorders
Dizziness
|
4.0%
2/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.2%
3/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
4.3%
2/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
6.4%
3/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
2.1%
1/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
40.0%
20/50 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
20.8%
10/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
31.9%
15/47 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
20.8%
10/48 • AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and up to of 66 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER