Trial Outcomes & Findings for A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients (NCT NCT02516605)
NCT ID: NCT02516605
Last Updated: 2021-01-05
Results Overview
Fold change in serum gamma-glutamyl transferase (GGT) from baseline to Day 28
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Baseline to Day 28
Results posted on
2021-01-05
Participant Flow
This study comprised of an escalating multiple dose design in PBC patients with incomplete biochemical response to, but still taking, ursodeoxycholic acid (UDCA).
Participant milestones
| Measure |
LJN452 - 0.03 mg qd
Tropifexor 0.03 mg daily for 28 days
|
LJN452 - 0.06 mg qd
Tropifexor 0.06 mg daily for 28 days
|
LJN452 - 0.09 mg qd
Tropifexor 0.09 mg daily for 28 days
|
LJN452 - 0.15 mg qd
Tropifexor 0.15 mg daily for 28 days
|
Placebo qd
Tropifexor placebo daily for 28 days
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
12
|
8
|
21
|
|
Overall Study
COMPLETED
|
11
|
9
|
12
|
7
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
LJN452 - 0.03 mg qd
Tropifexor 0.03 mg daily for 28 days
|
LJN452 - 0.06 mg qd
Tropifexor 0.06 mg daily for 28 days
|
LJN452 - 0.09 mg qd
Tropifexor 0.09 mg daily for 28 days
|
LJN452 - 0.15 mg qd
Tropifexor 0.15 mg daily for 28 days
|
Placebo qd
Tropifexor placebo daily for 28 days
|
|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients
Baseline characteristics by cohort
| Measure |
LJN452 - 0.03 mg qd
n=11 Participants
Tropifexor 0.03 mg daily for 28 days
|
LJN452 - 0.06 mg qd
n=9 Participants
Tropifexor 0.06 mg daily for 28 days
|
LJN452 - 0.09 mg qd
n=12 Participants
Tropifexor 0.09 mg daily for 28 days
|
LJN452 - 0.15 mg qd
n=8 Participants
Tropifexor 0.15 mg daily for 28 days
|
Placebo qd
n=21 Participants
Tropifexor placebo daily for 28 days
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 12.42 • n=5 Participants
|
57.9 years
STANDARD_DEVIATION 11.21 • n=7 Participants
|
53.6 years
STANDARD_DEVIATION 7.42 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 13.81 • n=4 Participants
|
53.7 years
STANDARD_DEVIATION 10.19 • n=21 Participants
|
55.7 years
STANDARD_DEVIATION 10.70 • n=10 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
59 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
12 participants
n=5 Participants
|
8 participants
n=4 Participants
|
19 participants
n=21 Participants
|
57 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
3 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: The PD analysis set included all subjects with any available PD data and no protocol deviations with relevant impact on PD data.
Fold change in serum gamma-glutamyl transferase (GGT) from baseline to Day 28
Outcome measures
| Measure |
LJN452 - 0.03 mg qd
n=10 Participants
Tropifexor 0.03 mg daily for 28 days.
|
LJN452 - 0.06 mg qd
n=9 Participants
Tropifexor 0.06 mg daily for 28 days
|
LJN452 - 0.09 mg qd
n=12 Participants
Tropifexor 0.09 mg daily for 28 days
|
LJN452 - 0.15 mg qd
n=8 Participants
Tropifexor 0.15 mg daily for 28 days
|
Pooled Placebo
n=20 Participants
Placebo data from all cohorts were pooled.
|
|---|---|---|---|---|---|
|
Fold Change in Serum Gamma-glutamyl Transferase (GGT)
|
0.74 fold-change
Interval 0.61 to 0.9
|
0.41 fold-change
Interval 0.33 to 0.5
|
0.28 fold-change
Interval 0.23 to 0.33
|
0.31 fold-change
Interval 0.24 to 0.4
|
0.86 fold-change
Interval 0.75 to 0.99
|
PRIMARY outcome
Timeframe: Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84Population: Safety Analysis Set
Vital signs - Systolic Blood pressure
Outcome measures
| Measure |
LJN452 - 0.03 mg qd
n=11 Participants
Tropifexor 0.03 mg daily for 28 days.
|
LJN452 - 0.06 mg qd
n=9 Participants
Tropifexor 0.06 mg daily for 28 days
|
LJN452 - 0.09 mg qd
n=12 Participants
Tropifexor 0.09 mg daily for 28 days
|
LJN452 - 0.15 mg qd
n=8 Participants
Tropifexor 0.15 mg daily for 28 days
|
Pooled Placebo
n=21 Participants
Placebo data from all cohorts were pooled.
|
|---|---|---|---|---|---|
|
Blood Pressure
Screening
|
122.5 mm Hg
Standard Deviation 12.21
|
125.8 mm Hg
Standard Deviation 11.79
|
129.3 mm Hg
Standard Deviation 14.42
|
129.5 mm Hg
Standard Deviation 17.42
|
123.0 mm Hg
Standard Deviation 15.40
|
|
Blood Pressure
Baseline
|
124.7 mm Hg
Standard Deviation 17.66
|
128.4 mm Hg
Standard Deviation 13.83
|
122.0 mm Hg
Standard Deviation 18.18
|
132.3 mm Hg
Standard Deviation 18.09
|
118.7 mm Hg
Standard Deviation 12.76
|
|
Blood Pressure
Day 1
|
129.6 mm Hg
Standard Deviation 20.48
|
122.4 mm Hg
Standard Deviation 20.24
|
119.9 mm Hg
Standard Deviation 11.84
|
129.1 mm Hg
Standard Deviation 25.12
|
123.0 mm Hg
Standard Deviation 21.84
|
|
Blood Pressure
Day 7
|
127.2 mm Hg
Standard Deviation 20.18
|
123.7 mm Hg
Standard Deviation 13.04
|
125.6 mm Hg
Standard Deviation 14.22
|
128.0 mm Hg
Standard Deviation 26.58
|
120.9 mm Hg
Standard Deviation 19.57
|
|
Blood Pressure
Day 14
|
122.4 mm Hg
Standard Deviation 16.30
|
124.6 mm Hg
Standard Deviation 20.67
|
127.1 mm Hg
Standard Deviation 16.45
|
127.3 mm Hg
Standard Deviation 12.45
|
118.7 mm Hg
Standard Deviation 12.88
|
|
Blood Pressure
Day 21
|
121.5 mm Hg
Standard Deviation 11.25
|
126.3 mm Hg
Standard Deviation 27.65
|
123.9 mm Hg
Standard Deviation 13.14
|
124.0 mm Hg
Standard Deviation 14.23
|
124.5 mm Hg
Standard Deviation 19.8
|
|
Blood Pressure
Day 28
|
118.0 mm Hg
Standard Deviation 11.22
|
127.1 mm Hg
Standard Deviation 28.55
|
121.4 mm Hg
Standard Deviation 12.82
|
126.0 mm Hg
Standard Deviation 7.71
|
120.1 mm Hg
Standard Deviation 22.38
|
|
Blood Pressure
Day 56
|
121.4 mm Hg
Standard Deviation 10.76
|
125.4 mm Hg
Standard Deviation 18.48
|
121.5 mm Hg
Standard Deviation 11.55
|
129.1 mm Hg
Standard Deviation 26.45
|
123.8 mm Hg
Standard Deviation 19.74
|
|
Blood Pressure
Day 84
|
131.3 mm Hg
Standard Deviation 16.04
|
124.6 mm Hg
Standard Deviation 15.77
|
122.3 mm Hg
Standard Deviation 7.70
|
130.4 mm Hg
Standard Deviation 25.51
|
123.6 mm Hg
Standard Deviation 19.09
|
PRIMARY outcome
Timeframe: Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84Population: Safety Analysis Set
Vital signs
Outcome measures
| Measure |
LJN452 - 0.03 mg qd
n=11 Participants
Tropifexor 0.03 mg daily for 28 days.
|
LJN452 - 0.06 mg qd
n=9 Participants
Tropifexor 0.06 mg daily for 28 days
|
LJN452 - 0.09 mg qd
n=12 Participants
Tropifexor 0.09 mg daily for 28 days
|
LJN452 - 0.15 mg qd
n=8 Participants
Tropifexor 0.15 mg daily for 28 days
|
Pooled Placebo
n=21 Participants
Placebo data from all cohorts were pooled.
|
|---|---|---|---|---|---|
|
Pulse Rate
Screening
|
68.6 bpm
Standard Deviation 10.63
|
61.2 bpm
Standard Deviation 7.05
|
75.3 bpm
Standard Deviation 8.22
|
72.8 bpm
Standard Deviation 8.26
|
69.3 bpm
Standard Deviation 10.69
|
|
Pulse Rate
Baseline
|
64.3 bpm
Standard Deviation 7.79
|
64.1 bpm
Standard Deviation 8.70
|
70.8 bpm
Standard Deviation 8.63
|
74.4 bpm
Standard Deviation 5.15
|
66.3 bpm
Standard Deviation 9.30
|
|
Pulse Rate
Day 1
|
67.7 bpm
Standard Deviation 11.93
|
64.2 bpm
Standard Deviation 8.07
|
69.7 bpm
Standard Deviation 7.50
|
74.1 bpm
Standard Deviation 11.62
|
67.6 bpm
Standard Deviation 8.35
|
|
Pulse Rate
Day 7
|
65.2 bpm
Standard Deviation 9.98
|
66.8 bpm
Standard Deviation 11.31
|
70.1 bpm
Standard Deviation 11.64
|
73.5 bpm
Standard Deviation 8.33
|
65.2 bpm
Standard Deviation 8.92
|
|
Pulse Rate
Day 14
|
62.9 bpm
Standard Deviation 10.03
|
64.8 bpm
Standard Deviation 8.09
|
70.5 bpm
Standard Deviation 14.16
|
75.1 bpm
Standard Deviation 6.74
|
66.1 bpm
Standard Deviation 9.61
|
|
Pulse Rate
Day 21
|
65.5 bpm
Standard Deviation 8.26
|
65.8 bpm
Standard Deviation 11.18
|
73.2 bpm
Standard Deviation 8.43
|
72.5 bpm
Standard Deviation 6.75
|
67.7 bpm
Standard Deviation 10.18
|
|
Pulse Rate
Day 28
|
65.5 bpm
Standard Deviation 10.83
|
68.9 bpm
Standard Deviation 10.60
|
68.5 bpm
Standard Deviation 9.01
|
67.2 bpm
Standard Deviation 3.42
|
65.8 bpm
Standard Deviation 9.29
|
|
Pulse Rate
Day 56
|
66.8 bpm
Standard Deviation 9.64
|
67.7 bpm
Standard Deviation 7.53
|
69.7 bpm
Standard Deviation 8.17
|
69.7 bpm
Standard Deviation 4.07
|
68.1 bpm
Standard Deviation 10.11
|
|
Pulse Rate
Day 84
|
65.6 bpm
Standard Deviation 10.24
|
64.0 bpm
Standard Deviation 9.11
|
70.2 bpm
Standard Deviation 8.14
|
72.8 bpm
Standard Deviation 8.12
|
68.1 bpm
Standard Deviation 9.82
|
PRIMARY outcome
Timeframe: Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84Population: Safety Analysis Set
Vital signs
Outcome measures
| Measure |
LJN452 - 0.03 mg qd
n=11 Participants
Tropifexor 0.03 mg daily for 28 days.
|
LJN452 - 0.06 mg qd
n=9 Participants
Tropifexor 0.06 mg daily for 28 days
|
LJN452 - 0.09 mg qd
n=12 Participants
Tropifexor 0.09 mg daily for 28 days
|
LJN452 - 0.15 mg qd
n=8 Participants
Tropifexor 0.15 mg daily for 28 days
|
Pooled Placebo
n=21 Participants
Placebo data from all cohorts were pooled.
|
|---|---|---|---|---|---|
|
Body Temperature
Screening
|
36.605 Celsius
Standard Deviation 0.2813
|
36.567 Celsius
Standard Deviation 0.2000
|
36.424 Celsius
Standard Deviation 0.3429
|
36.650 Celsius
Standard Deviation 0.1604
|
36.460 Celsius
Standard Deviation 0.4500
|
|
Body Temperature
baseline
|
36.582 Celsius
Standard Deviation 0.2960
|
36.644 Celsius
Standard Deviation 0.2128
|
36.398 Celsius
Standard Deviation 0.3385
|
36.638 Celsius
Standard Deviation 0.1506
|
36.376 Celsius
Standard Deviation 0.5118
|
|
Body Temperature
day 1
|
36.436 Celsius
Standard Deviation 0.3139
|
36.537 Celsius
Standard Deviation 0.3076
|
36.482 Celsius
Standard Deviation 0.2636
|
36.575 Celsius
Standard Deviation 0.1982
|
36.390 Celsius
Standard Deviation 0.4867
|
|
Body Temperature
day 7
|
36.582 Celsius
Standard Deviation 0.2040
|
36.533 Celsius
Standard Deviation 0.1323
|
36.258 Celsius
Standard Deviation 0.3965
|
36.600 Celsius
Standard Deviation 0.1195
|
36.345 Celsius
Standard Deviation 0.4639
|
|
Body Temperature
day 14
|
36.516 Celsius
Standard Deviation 0.1793
|
36.444 Celsius
Standard Deviation 0.2007
|
36.291 Celsius
Standard Deviation 0.4109
|
36.500 Celsius
Standard Deviation 0.1826
|
36.310 Celsius
Standard Deviation 0.4576
|
|
Body Temperature
day 21
|
36.500 Celsius
Standard Deviation 0.2490
|
36.267 Celsius
Standard Deviation 0.4637
|
36.308 Celsius
Standard Deviation 0.3288
|
36.433 Celsius
Standard Deviation 0.1966
|
36.455 Celsius
Standard Deviation 0.4236
|
|
Body Temperature
day 28
|
36.382 Celsius
Standard Deviation 0.2228
|
36.444 Celsius
Standard Deviation 0.2128
|
36.308 Celsius
Standard Deviation 0.3397
|
36.520 Celsius
Standard Deviation 0.2950
|
36.380 Celsius
Standard Deviation 0.4047
|
|
Body Temperature
day 56
|
36.527 Celsius
Standard Deviation 0.2102
|
36.500 Celsius
Standard Deviation 0.2179
|
36.350 Celsius
Standard Deviation 0.4602
|
36.443 Celsius
Standard Deviation 0.3309
|
36.285 Celsius
Standard Deviation 0.4246
|
|
Body Temperature
day 84
|
36.482 Celsius
Standard Deviation 0.2483
|
36.500 Celsius
Standard Deviation 0.1500
|
36.383 Celsius
Standard Deviation 0.2980
|
36.638 Celsius
Standard Deviation 0.1506
|
36.295 Celsius
Standard Deviation 0.4248
|
PRIMARY outcome
Timeframe: Screening, Baseline, day 1, day 28Population: Safety Analysis Set
Electrocardiogram (ECG)
Outcome measures
| Measure |
LJN452 - 0.03 mg qd
n=11 Participants
Tropifexor 0.03 mg daily for 28 days.
|
LJN452 - 0.06 mg qd
n=9 Participants
Tropifexor 0.06 mg daily for 28 days
|
LJN452 - 0.09 mg qd
n=12 Participants
Tropifexor 0.09 mg daily for 28 days
|
LJN452 - 0.15 mg qd
n=8 Participants
Tropifexor 0.15 mg daily for 28 days
|
Pooled Placebo
n=21 Participants
Placebo data from all cohorts were pooled.
|
|---|---|---|---|---|---|
|
ECG - Heart Rate
Screening
|
65.8 bpm
Standard Deviation 11.32
|
61.8 bpm
Standard Deviation 9.97
|
67.3 bpm
Standard Deviation 5.58
|
67.8 bpm
Standard Deviation 6.54
|
63.4 bpm
Standard Deviation 9.35
|
|
ECG - Heart Rate
Baseline
|
60.5 bpm
Standard Deviation 8.99
|
61.4 bpm
Standard Deviation 8.75
|
64.6 bpm
Standard Deviation 7.95
|
67.9 bpm
Standard Deviation 6.45
|
63.8 bpm
Standard Deviation 9.41
|
|
ECG - Heart Rate
Day 1
|
61.5 bpm
Standard Deviation 11.16
|
63.4 bpm
Standard Deviation 11.17
|
63.9 bpm
Standard Deviation 8.21
|
66.9 bpm
Standard Deviation 11.97
|
63.5 bpm
Standard Deviation 7.12
|
|
ECG - Heart Rate
Day 28
|
60.5 bpm
Standard Deviation 11.39
|
65.2 bpm
Standard Deviation 11.95
|
63.5 bpm
Standard Deviation 9.95
|
65.8 bpm
Standard Deviation 4.55
|
60.8 bpm
Standard Deviation 7.03
|
PRIMARY outcome
Timeframe: Screening, Baseline, day 1, day 28Population: Safety Analysis Set
Electrocardiogram (ECG)
Outcome measures
| Measure |
LJN452 - 0.03 mg qd
n=11 Participants
Tropifexor 0.03 mg daily for 28 days.
|
LJN452 - 0.06 mg qd
n=9 Participants
Tropifexor 0.06 mg daily for 28 days
|
LJN452 - 0.09 mg qd
n=12 Participants
Tropifexor 0.09 mg daily for 28 days
|
LJN452 - 0.15 mg qd
n=8 Participants
Tropifexor 0.15 mg daily for 28 days
|
Pooled Placebo
n=21 Participants
Placebo data from all cohorts were pooled.
|
|---|---|---|---|---|---|
|
ECG Intervals - PR Interval
Baseline
|
165.8 msec
Standard Deviation 20.81
|
156.2 msec
Standard Deviation 18.99
|
175.0 msec
Standard Deviation 34.96
|
152.0 msec
Standard Deviation 22.21
|
160.3 msec
Standard Deviation 19.77
|
|
ECG Intervals - PR Interval
Screening
|
159.2 msec
Standard Deviation 27.34
|
158.0 msec
Standard Deviation 23.71
|
172.0 msec
Standard Deviation 24.12
|
159.9 msec
Standard Deviation 17.24
|
162.6 msec
Standard Deviation 19.03
|
|
ECG Intervals - PR Interval
Day 1
|
165.5 msec
Standard Deviation 21.76
|
162.9 msec
Standard Deviation 27.06
|
175.7 msec
Standard Deviation 28.29
|
160.0 msec
Standard Deviation 20.32
|
161.6 msec
Standard Deviation 20.28
|
|
ECG Intervals - PR Interval
Day 28
|
164.9 msec
Standard Deviation 19.75
|
157.1 msec
Standard Deviation 26.70
|
180.4 msec
Standard Deviation 31.63
|
155.4 msec
Standard Deviation 23.51
|
160.2 msec
Standard Deviation 28.70
|
PRIMARY outcome
Timeframe: Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84Population: Safety Analysis Set
Hematology panel for safety laboratory assessments.
Outcome measures
| Measure |
LJN452 - 0.03 mg qd
n=11 Participants
Tropifexor 0.03 mg daily for 28 days.
|
LJN452 - 0.06 mg qd
n=9 Participants
Tropifexor 0.06 mg daily for 28 days
|
LJN452 - 0.09 mg qd
n=12 Participants
Tropifexor 0.09 mg daily for 28 days
|
LJN452 - 0.15 mg qd
n=8 Participants
Tropifexor 0.15 mg daily for 28 days
|
Pooled Placebo
n=21 Participants
Placebo data from all cohorts were pooled.
|
|---|---|---|---|---|---|
|
Haemoglobin
Screening
|
127.9 g/L
Standard Deviation 9.24
|
125.6 g/L
Standard Deviation 11.70
|
130.5 g/L
Standard Deviation 9.73
|
133.9 g/L
Standard Deviation 12.70
|
132.2 g/L
Standard Deviation 8.81
|
|
Haemoglobin
baseline
|
126.5 g/L
Standard Deviation 8.58
|
127.4 g/L
Standard Deviation 11.85
|
130.5 g/L
Standard Deviation 11.90
|
134.6 g/L
Standard Deviation 13.24
|
131.3 g/L
Standard Deviation 8.02
|
|
Haemoglobin
day 1
|
124.7 g/L
Standard Deviation 8.21
|
132.9 g/L
Standard Deviation 10.05
|
127.0 g/L
Standard Deviation 9.03
|
133.1 g/L
Standard Deviation 11.37
|
126.8 g/L
Standard Deviation 7.63
|
|
Haemoglobin
day 7
|
124.0 g/L
Standard Deviation 8.23
|
128.8 g/L
Standard Deviation 16.97
|
132.4 g/L
Standard Deviation 10.66
|
134.0 g/L
Standard Deviation 8.75
|
128.6 g/L
Standard Deviation 9.18
|
|
Haemoglobin
day 14
|
126.5 g/L
Standard Deviation 9.83
|
127.3 g/L
Standard Deviation 12.64
|
128.6 g/L
Standard Deviation 7.82
|
135.4 g/L
Standard Deviation 13.50
|
128.7 g/L
Standard Deviation 10.84
|
|
Haemoglobin
day 21
|
127.5 g/L
Standard Deviation 8.32
|
128.0 g/L
Standard Deviation 13.49
|
130.5 g/L
Standard Deviation 10.40
|
134.2 g/L
Standard Deviation 9.91
|
128.8 g/L
Standard Deviation 10.79
|
|
Haemoglobin
day 28
|
125.3 g/L
Standard Deviation 9.18
|
127.1 g/L
Standard Deviation 14.67
|
129.6 g/L
Standard Deviation 10.02
|
136.4 g/L
Standard Deviation 13.50
|
125.7 g/L
Standard Deviation 9.71
|
|
Haemoglobin
day 56
|
126.7 g/L
Standard Deviation 6.96
|
125.8 g/L
Standard Deviation 11.15
|
128.6 g/L
Standard Deviation 10.63
|
133.6 g/L
Standard Deviation 12.00
|
129.3 g/L
Standard Deviation 11.39
|
|
Haemoglobin
day 84
|
126.5 g/L
Standard Deviation 8.78
|
124.9 g/L
Standard Deviation 9.75
|
125.9 g/L
Standard Deviation 11.19
|
131.1 g/L
Standard Deviation 10.91
|
129.3 g/L
Standard Deviation 9.24
|
SECONDARY outcome
Timeframe: Day 1, Day 28Population: The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.
Tropifexor levels were determined in plasma using a validated LC-MS/MS method. AUC0-t=The area under the plasma concentration-time curve from time zero to time 't' where t is a defined time point after administration \[mass x time / volume\]
Outcome measures
| Measure |
LJN452 - 0.03 mg qd
n=9 Participants
Tropifexor 0.03 mg daily for 28 days.
|
LJN452 - 0.06 mg qd
n=7 Participants
Tropifexor 0.06 mg daily for 28 days
|
LJN452 - 0.09 mg qd
n=3 Participants
Tropifexor 0.09 mg daily for 28 days
|
LJN452 - 0.15 mg qd
n=4 Participants
Tropifexor 0.15 mg daily for 28 days
|
Pooled Placebo
Placebo data from all cohorts were pooled.
|
|---|---|---|---|---|---|
|
Plasma PK Parameter - AUC 0-8h
Day 1
|
4.98 hr*ng/mL
Standard Deviation 2.87
|
12.1 hr*ng/mL
Standard Deviation 2.68
|
—
|
24.5 hr*ng/mL
Standard Deviation 15.9
|
—
|
|
Plasma PK Parameter - AUC 0-8h
Day 28
|
7.95 hr*ng/mL
Standard Deviation 4.21
|
17.6 hr*ng/mL
Standard Deviation 5.30
|
23.4 hr*ng/mL
Standard Deviation 8.70
|
44.2 hr*ng/mL
Standard Deviation 25.8
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 28Population: The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.
Tropifexor levels were determined in plasma using a validated LC-MS/MS method. Cmax=The observed maximum plasma concentration following drug administration \[mass /volume\]
Outcome measures
| Measure |
LJN452 - 0.03 mg qd
n=11 Participants
Tropifexor 0.03 mg daily for 28 days.
|
LJN452 - 0.06 mg qd
n=9 Participants
Tropifexor 0.06 mg daily for 28 days
|
LJN452 - 0.09 mg qd
n=12 Participants
Tropifexor 0.09 mg daily for 28 days
|
LJN452 - 0.15 mg qd
n=8 Participants
Tropifexor 0.15 mg daily for 28 days
|
Pooled Placebo
Placebo data from all cohorts were pooled.
|
|---|---|---|---|---|---|
|
Plasma PK Parameter - Cmax
Day 1
|
1.04 ng/mL
Standard Deviation 0.484
|
1.80 ng/mL
Standard Deviation 0.585
|
2.37 ng/mL
Standard Deviation 1.56
|
4.84 ng/mL
Standard Deviation 2.59
|
—
|
|
Plasma PK Parameter - Cmax
Day 28
|
1.25 ng/mL
Standard Deviation 0.559
|
2.55 ng/mL
Standard Deviation 0.946
|
4.30 ng/mL
Standard Deviation 2.10
|
6.37 ng/mL
Standard Deviation 3.40
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 28Population: The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.
Tropifexor levels were determined in plasma using a validated LC-MS/MS method. Tmax = The time to reach the maximum concentration after drug administration \[time\]
Outcome measures
| Measure |
LJN452 - 0.03 mg qd
n=11 Participants
Tropifexor 0.03 mg daily for 28 days.
|
LJN452 - 0.06 mg qd
n=9 Participants
Tropifexor 0.06 mg daily for 28 days
|
LJN452 - 0.09 mg qd
n=12 Participants
Tropifexor 0.09 mg daily for 28 days
|
LJN452 - 0.15 mg qd
n=8 Participants
Tropifexor 0.15 mg daily for 28 days
|
Pooled Placebo
Placebo data from all cohorts were pooled.
|
|---|---|---|---|---|---|
|
Plasma PK Parameter - Tmax
Day 1
|
4.12 hr
Interval 2.0 to 8.0
|
4.00 hr
Interval 3.7 to 6.0
|
4.00 hr
Interval 0.0 to 7.83
|
4.00 hr
Interval 4.0 to 4.18
|
—
|
|
Plasma PK Parameter - Tmax
Day 28
|
4.08 hr
Interval 2.0 to 8.0
|
4.00 hr
Interval 3.13 to 7.6
|
4.00 hr
Interval 0.0 to 6.0
|
5.00 hr
Interval 3.03 to 6.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 28, Day 56, Day 84Population: The PD analysis set included all subjects with any available PD data and no protocol deviations with relevant impact on PD data.
Baseline is defined as the latest available predose value. The PBC-40 is a paper-based, patient-derived, disease-specific health-related quality of life (HRQOL) patient reported outcome (PRO) measure which was developed and validated for use in PBC patients (Jacoby et al 2005). It consists of 40 questions arranged in 6 domains with between 3 and 11 questions in each domain. Each question is scored from 1 to 5 in increasing order of severity. All questions within a domain are summed and all domain totals are summed to obtain a total score. The total score range is between a minimum of 40 and a maximum of 200. Higher scores represent a poorer quality of life. The median difference from baseline in total sum score for each treatment group is presented.
Outcome measures
| Measure |
LJN452 - 0.03 mg qd
n=10 Participants
Tropifexor 0.03 mg daily for 28 days.
|
LJN452 - 0.06 mg qd
n=9 Participants
Tropifexor 0.06 mg daily for 28 days
|
LJN452 - 0.09 mg qd
n=12 Participants
Tropifexor 0.09 mg daily for 28 days
|
LJN452 - 0.15 mg qd
n=8 Participants
Tropifexor 0.15 mg daily for 28 days
|
Pooled Placebo
n=20 Participants
Placebo data from all cohorts were pooled.
|
|---|---|---|---|---|---|
|
Changes From Baseline in Total PBC-40 Score
Day 28
|
2.0 units on a scale
Interval -10.0 to 7.0
|
1.0 units on a scale
Interval -14.0 to 16.0
|
3.5 units on a scale
Interval -7.0 to 13.0
|
-1.0 units on a scale
Interval -5.0 to 43.0
|
-2.0 units on a scale
Interval -23.0 to 26.0
|
|
Changes From Baseline in Total PBC-40 Score
Day 56
|
3.0 units on a scale
Interval -7.0 to 29.0
|
3.0 units on a scale
Interval -15.0 to 23.0
|
-2.5 units on a scale
Interval -15.0 to 16.0
|
-3.0 units on a scale
Interval -28.0 to 3.0
|
1.0 units on a scale
Interval -12.0 to 30.0
|
|
Changes From Baseline in Total PBC-40 Score
Day 84
|
-2.0 units on a scale
Interval -12.0 to 13.0
|
-1.0 units on a scale
Interval -14.0 to 16.0
|
-3.5 units on a scale
Interval -38.0 to 10.0
|
-1.0 units on a scale
Interval -12.0 to 5.0
|
1.5 units on a scale
Interval -38.0 to 30.0
|
SECONDARY outcome
Timeframe: Baseline, Day 28, Day 56, Day 84Population: The PD analysis set included all subjects with any available PD data and no protocol deviations with relevant impact on PD data.
Baseline is defined as the latest available predose value. The PBC-40 is a paper-based, patient-derived, disease-specific health-related quality of life (HRQOL) patient reported outcome (PRO) measure which was developed and validated for use in PBC patients (Jacoby et al 2005). It consists of 40 questions arranged in 6 domains with between 3 and 11 questions in each domain. Each question is scored from 1 to 5 in increasing order of severity. This dataset focuses on the itch subdomain which consists of 3 questions. These 3 questions within the itch subdomain are summed to obtain a total score for the itch subdomain. The total score range is between a minimum of 3 and a maximum of 15. Higher scores represent a poorer quality of life. The median change from baseline in total itch subdomain score in each treatment group is presented.
Outcome measures
| Measure |
LJN452 - 0.03 mg qd
n=10 Participants
Tropifexor 0.03 mg daily for 28 days.
|
LJN452 - 0.06 mg qd
n=9 Participants
Tropifexor 0.06 mg daily for 28 days
|
LJN452 - 0.09 mg qd
n=12 Participants
Tropifexor 0.09 mg daily for 28 days
|
LJN452 - 0.15 mg qd
n=8 Participants
Tropifexor 0.15 mg daily for 28 days
|
Pooled Placebo
n=20 Participants
Placebo data from all cohorts were pooled.
|
|---|---|---|---|---|---|
|
Change From Baseline in Itch Subdomain of PBC-40 Score
Day 28
|
1.0 UNITS ON A SCALE
Interval -2.0 to 7.0
|
1.0 UNITS ON A SCALE
Interval 0.0 to 2.0
|
2.0 UNITS ON A SCALE
Interval -2.0 to 10.0
|
2.0 UNITS ON A SCALE
Interval 0.0 to 7.0
|
0.0 UNITS ON A SCALE
Interval -4.0 to 9.0
|
|
Change From Baseline in Itch Subdomain of PBC-40 Score
Day 56
|
1.0 UNITS ON A SCALE
Interval -9.0 to 4.0
|
1.0 UNITS ON A SCALE
Interval 0.0 to 6.0
|
0.5 UNITS ON A SCALE
Interval -3.0 to 5.0
|
0.0 UNITS ON A SCALE
Interval 0.0 to 1.0
|
0.0 UNITS ON A SCALE
Interval -3.0 to 12.0
|
|
Change From Baseline in Itch Subdomain of PBC-40 Score
Day 84
|
0.0 UNITS ON A SCALE
Interval -6.0 to 1.0
|
0.0 UNITS ON A SCALE
Interval -2.0 to 2.0
|
0.0 UNITS ON A SCALE
Interval -4.0 to 8.0
|
0.0 UNITS ON A SCALE
Interval -1.0 to 1.0
|
0.0 UNITS ON A SCALE
Interval -3.0 to 8.0
|
SECONDARY outcome
Timeframe: Day 7, Day 14, Day 21, Day 28, Day 56, and Day 84Population: The PD analysis set included all subjects with any available PD data and no protocol deviations with relevant impact on PD data.
Baseline is defined as the latest available predose value. The Global Itch Visual Analogue Scale, a 100 mm visual analogue scale (VAS), was used to assess the severity of patients itch (ranging from 0 = none at all to 100 = the worst imaginable itch). The score range is between a minimum of 0 and a maximum of 100. The score (distance in mm from left) on the VAS was recorded by the patient marking with a line and used to test for an effect of tropifexor over placebo. The mean change from baseline in itch VAS score in each treatment group is presented.
Outcome measures
| Measure |
LJN452 - 0.03 mg qd
n=10 Participants
Tropifexor 0.03 mg daily for 28 days.
|
LJN452 - 0.06 mg qd
n=9 Participants
Tropifexor 0.06 mg daily for 28 days
|
LJN452 - 0.09 mg qd
n=12 Participants
Tropifexor 0.09 mg daily for 28 days
|
LJN452 - 0.15 mg qd
n=8 Participants
Tropifexor 0.15 mg daily for 28 days
|
Pooled Placebo
n=20 Participants
Placebo data from all cohorts were pooled.
|
|---|---|---|---|---|---|
|
Change From Baseline in Global Itch Visual Analogue Scale (VAS)
Day 7
|
-2.04 mm
Interval -13.84 to 9.75
|
12.08 mm
Interval 0.33 to 23.83
|
14.66 mm
Interval 4.16 to 25.16
|
27.45 mm
Interval 15.0 to 39.89
|
0.74 mm
Interval -7.17 to 8.66
|
|
Change From Baseline in Global Itch Visual Analogue Scale (VAS)
Day 14
|
-8.04 mm
Interval -19.55 to 3.48
|
13.77 mm
Interval 2.3 to 25.23
|
6.51 mm
Interval -3.76 to 16.78
|
14.20 mm
Interval 1.26 to 27.13
|
6.03 mm
Interval -1.7 to 13.76
|
|
Change From Baseline in Global Itch Visual Analogue Scale (VAS)
Day 21
|
10.53 mm
Interval -1.66 to 22.72
|
19.54 mm
Interval 7.4 to 31.68
|
7.76 mm
Interval -3.11 to 18.64
|
8.65 mm
Interval -5.9 to 23.2
|
2.74 mm
Interval -5.44 to 10.93
|
|
Change From Baseline in Global Itch Visual Analogue Scale (VAS)
Day 28
|
8.62 mm
Interval -4.24 to 21.48
|
15.64 mm
Interval 2.83 to 28.44
|
1.78 mm
Interval -9.69 to 13.26
|
10.50 mm
Interval -5.52 to 26.51
|
1.59 mm
Interval -7.04 to 10.22
|
|
Change From Baseline in Global Itch Visual Analogue Scale (VAS)
Day 56
|
-7.81 mm
Interval -17.87 to 2.26
|
5.69 mm
Interval -4.33 to 15.72
|
-6.38 mm
Interval -15.35 to 2.59
|
-3.64 mm
Interval -14.58 to 7.3
|
7.44 mm
Interval 0.68 to 14.2
|
|
Change From Baseline in Global Itch Visual Analogue Scale (VAS)
Day 84
|
-5.14 mm
Interval -17.15 to 6.88
|
0.89 mm
Interval -11.08 to 12.85
|
-6.44 mm
Interval -17.13 to 4.26
|
-5.14 mm
Interval -17.81 to 7.53
|
11.79 mm
Interval 3.73 to 19.86
|
Adverse Events
LJN452 - 0.03 mg qd
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
LJN452 - 0.06 mg qd
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
LJN452 - 0.09 mg qd
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
LJN452 - 0.15 mg qd
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo qd
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LJN452 - 0.03 mg qd
n=11 participants at risk
Tropifexor 0.03 mg daily for 28 days
|
LJN452 - 0.06 mg qd
n=9 participants at risk
Tropifexor 0.06 mg daily for 28 days
|
LJN452 - 0.09 mg qd
n=12 participants at risk
Tropifexor 0.09 mg daily for 28 days
|
LJN452 - 0.15 mg qd
n=8 participants at risk
Tropifexor 0.15 mg daily for 28 days
|
Placebo qd
n=21 participants at risk
Tropifexor placebo daily for 28 days
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Sleep disorder
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
12.5%
1/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
8.3%
1/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
12.5%
1/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Renal and urinary disorders
Proteinuria
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
12.5%
1/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
8.3%
1/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
8.3%
1/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
12.5%
1/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Nervous system disorders
Dysgeusia
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Nervous system disorders
Headache
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
16.7%
2/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
12.5%
1/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
14.3%
3/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
8.3%
1/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
12.5%
1/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Investigations
Weight increased
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
12.5%
1/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
9.5%
2/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
11.1%
1/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
11.1%
1/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
18.2%
2/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
11.1%
1/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
11.1%
1/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
11.1%
1/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Cardiac disorders
Trifascicular block
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
11.1%
1/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Eye disorders
Dry eye
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
11.1%
1/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
18.2%
2/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
8.3%
1/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
14.3%
3/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
11.1%
1/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
8.3%
1/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
8.3%
1/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
22.2%
2/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
12.5%
1/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Gastrointestinal disorders
Flatulence
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
8.3%
1/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
12.5%
1/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
11.1%
1/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
16.7%
2/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
14.3%
3/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
11.1%
1/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
9.5%
2/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
General disorders
Fatigue
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
8.3%
1/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
12.5%
1/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
General disorders
Non-cardiac chest pain
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
General disorders
Oedema peripheral
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
9.5%
2/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Infections and infestations
Fungal infection
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Infections and infestations
Nasopharyngitis
|
18.2%
2/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
8.3%
1/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Infections and infestations
Overgrowth bacterial
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
8.3%
1/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Infections and infestations
Rash pustular
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Infections and infestations
Sinusitis
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Infections and infestations
Tooth abscess
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
11.1%
1/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
16.7%
2/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Infections and infestations
Viral infection
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
12.5%
1/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
12.5%
1/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
18.2%
2/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
25.0%
2/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
12.5%
1/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
8.3%
1/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
8.3%
1/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
8.3%
1/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.3%
3/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
66.7%
6/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
41.7%
5/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
87.5%
7/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
28.6%
6/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
8.3%
1/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
11.1%
1/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
12.5%
1/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
4.8%
1/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
8.3%
1/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
|
Vascular disorders
Hypertension
|
9.1%
1/11 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/9 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/12 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/8 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
|
0.00%
0/21 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
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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