Trial Outcomes & Findings for A Ph2b to Evaluate Clinical Efficacy and Safety of Tildacerfont in Adult CAH (NCT NCT04457336)
NCT ID: NCT04457336
Last Updated: 2025-07-08
Results Overview
Assessment of dose response for change from baseline in log A4 after 12 weeks on double-blind placebo-controlled treatment (Week 18)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
Baseline and 12 weeks of treatment (Week 18)
Results posted on
2025-07-08
Participant Flow
96 participants participated in Part A , 86 of those participants continued into Part B, and 57 of these participants then entered Part C
96 informed consents were signed when participants enrolled in the Placebo or Part A of the study. The ICF included language for all Parts of the study.
Participant milestones
| Measure |
Period 1: Placebo
Placebo
|
Period 2: Part A 50 mg
Tildacerfont 50 mg
|
Period 2: Part A 100 mg
Tildacerfont 100 mg
|
Period 2: Part A 200 mg
Tildacerfont 200 mg
|
Period 3: Part B 50 mg
Tildacerfont 50 mg
|
Period 3: Part B 100 mg
Tildacerfont 100 mg
|
Period 3: Part B 200 mg
Tildacerfont 200 mg
|
Period 4: Part C
Tildacerfont tablet administered daily via oral tablet for 46 weeks at 200 mg
|
|---|---|---|---|---|---|---|---|---|
|
Period 1: Placebo
STARTED
|
24
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1: Placebo
COMPLETED
|
24
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1: Placebo
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2: Part A
STARTED
|
0
|
24
|
24
|
24
|
0
|
0
|
0
|
0
|
|
Period 2: Part A
COMPLETED
|
0
|
20
|
21
|
21
|
0
|
0
|
0
|
0
|
|
Period 2: Part A
NOT COMPLETED
|
0
|
4
|
3
|
3
|
0
|
0
|
0
|
0
|
|
Period 3: Part B
STARTED
|
0
|
0
|
0
|
0
|
1
|
44
|
41
|
0
|
|
Period 3: Part B
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
33
|
26
|
0
|
|
Period 3: Part B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
11
|
15
|
0
|
|
Period 4: Part C
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
57
|
|
Period 4: Part C
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
19
|
|
Period 4: Part C
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
38
|
Reasons for withdrawal
| Measure |
Period 1: Placebo
Placebo
|
Period 2: Part A 50 mg
Tildacerfont 50 mg
|
Period 2: Part A 100 mg
Tildacerfont 100 mg
|
Period 2: Part A 200 mg
Tildacerfont 200 mg
|
Period 3: Part B 50 mg
Tildacerfont 50 mg
|
Period 3: Part B 100 mg
Tildacerfont 100 mg
|
Period 3: Part B 200 mg
Tildacerfont 200 mg
|
Period 4: Part C
Tildacerfont tablet administered daily via oral tablet for 46 weeks at 200 mg
|
|---|---|---|---|---|---|---|---|---|
|
Period 2: Part A
Withdrawal by Subject
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Period 2: Part A
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Period 2: Part A
Study Terminated
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 2: Part A
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2: Part A
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2: Part A
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2: Part A
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 3: Part B
Study Terminated
|
0
|
0
|
0
|
0
|
1
|
10
|
13
|
0
|
|
Period 3: Part B
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
|
Period 4: Part C
Study Terminated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
30
|
|
Period 4: Part C
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Period 4: Part C
Site Terminated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 4: Part C
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Period 4: Part C
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
A Ph2b to Evaluate Clinical Efficacy and Safety of Tildacerfont in Adult CAH
Baseline characteristics by cohort
| Measure |
Placebo
n=24 Participants
tablet
|
Tildacerfont 50 mg
n=24 Participants
50 mg
|
Tildacerfont 100 mg
n=24 Participants
100 mg
|
Tildacerfont 200 mg
n=24 Participants
200 mg
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.5 years
STANDARD_DEVIATION 12.03 • n=5 Participants
|
29.1 years
STANDARD_DEVIATION 11.55 • n=7 Participants
|
31.5 years
STANDARD_DEVIATION 8.29 • n=5 Participants
|
35.1 years
STANDARD_DEVIATION 11.36 • n=4 Participants
|
32.3 years
STANDARD_DEVIATION 10.81 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
BMI
|
31.46 kg/m^2
STANDARD_DEVIATION 9.29 • n=5 Participants
|
31.27 kg/m^2
STANDARD_DEVIATION 7.675 • n=7 Participants
|
30.98 kg/m^2
STANDARD_DEVIATION 7.521 • n=5 Participants
|
30.25 kg/m^2
STANDARD_DEVIATION 4.453 • n=4 Participants
|
30.99 kg/m^2
STANDARD_DEVIATION 7.23 • n=21 Participants
|
|
Waist Circumference
|
95.8 cm
STANDARD_DEVIATION 17.074 • n=5 Participants
|
98.78 cm
STANDARD_DEVIATION 19.135 • n=7 Participants
|
97.98 cm
STANDARD_DEVIATION 19.148 • n=5 Participants
|
99.31 cm
STANDARD_DEVIATION 12.407 • n=4 Participants
|
97.968 cm
STANDARD_DEVIATION 16.941 • n=21 Participants
|
|
Daily dose of Glucocorticoid
|
26.9 mg in hydrocortisone equivalent(s)
STANDARD_DEVIATION 7.59 • n=5 Participants
|
29.1 mg in hydrocortisone equivalent(s)
STANDARD_DEVIATION 10.83 • n=7 Participants
|
25.4 mg in hydrocortisone equivalent(s)
STANDARD_DEVIATION 6.71 • n=5 Participants
|
26.7 mg in hydrocortisone equivalent(s)
STANDARD_DEVIATION 8.94 • n=4 Participants
|
27.025 mg in hydrocortisone equivalent(s)
STANDARD_DEVIATION 8.518 • n=21 Participants
|
|
Glucocorticoid BSA Based Dose
|
13.97 mg in hydrocortisone equivalent(s)/m^2
STANDARD_DEVIATION 4.198 • n=5 Participants
|
14.62 mg in hydrocortisone equivalent(s)/m^2
STANDARD_DEVIATION 4.880 • n=7 Participants
|
13.52 mg in hydrocortisone equivalent(s)/m^2
STANDARD_DEVIATION 4.117 • n=5 Participants
|
14.21 mg in hydrocortisone equivalent(s)/m^2
STANDARD_DEVIATION 12.5 • n=4 Participants
|
14.08 mg in hydrocortisone equivalent(s)/m^2
STANDARD_DEVIATION 6.424 • n=21 Participants
|
|
Systolic blood pressure
|
118.3 mmHg
STANDARD_DEVIATION 10.08 • n=5 Participants
|
117.5 mmHg
STANDARD_DEVIATION 9.54 • n=7 Participants
|
115.0 mmHg
STANDARD_DEVIATION 10.46 • n=5 Participants
|
120.4 mmHg
STANDARD_DEVIATION 13.71 • n=4 Participants
|
117.8 mmHg
STANDARD_DEVIATION 10.946 • n=21 Participants
|
|
Diastolic blood pressure
|
78.1 mmHg
STANDARD_DEVIATION 9.15 • n=5 Participants
|
76.4 mmHg
STANDARD_DEVIATION 7.03 • n=7 Participants
|
77.6 mmHg
STANDARD_DEVIATION 8.41 • n=5 Participants
|
76.8 mmHg
STANDARD_DEVIATION 10.27 • n=4 Participants
|
77.225 mmHg
STANDARD_DEVIATION 8.715 • n=21 Participants
|
|
HbA1c
|
5.18 % of Hemoglobin
STANDARD_DEVIATION 0.215 • n=5 Participants
|
5.14 % of Hemoglobin
STANDARD_DEVIATION 0.255 • n=7 Participants
|
5.33 % of Hemoglobin
STANDARD_DEVIATION 0.944 • n=5 Participants
|
5.27 % of Hemoglobin
STANDARD_DEVIATION 0.218 • n=4 Participants
|
5.23 % of Hemoglobin
STANDARD_DEVIATION 0.408 • n=21 Participants
|
|
Fasting glucose
|
89.1 mg/dL
STANDARD_DEVIATION 11.94 • n=5 Participants
|
91.1 mg/dL
STANDARD_DEVIATION 9.57 • n=7 Participants
|
91.4 mg/dL
STANDARD_DEVIATION 8.36 • n=5 Participants
|
90.8 mg/dL
STANDARD_DEVIATION 10.03 • n=4 Participants
|
90.6 mg/dL
STANDARD_DEVIATION 9.975 • n=21 Participants
|
|
Fasting insulin
|
10.32 uIU/mL
STANDARD_DEVIATION 5.491 • n=5 Participants
|
16.72 uIU/mL
STANDARD_DEVIATION 9.896 • n=7 Participants
|
15.77 uIU/mL
STANDARD_DEVIATION 15.89 • n=5 Participants
|
16.45 uIU/mL
STANDARD_DEVIATION 11.004 • n=4 Participants
|
14.815 uIU/mL
STANDARD_DEVIATION 10.57 • n=21 Participants
|
|
Homeostatic model assessment of insulin resistance (HOMA-IR)
|
2.33 units on a scale
STANDARD_DEVIATION 1.376 • n=5 Participants
|
3.84 units on a scale
STANDARD_DEVIATION 2.507 • n=7 Participants
|
3.66 units on a scale
STANDARD_DEVIATION 3.90 • n=5 Participants
|
3.79 units on a scale
STANDARD_DEVIATION 2.774 • n=4 Participants
|
3.405 units on a scale
STANDARD_DEVIATION 2.639 • n=21 Participants
|
|
Total cholesterol
|
169.3 mg/dL
STANDARD_DEVIATION 41.62 • n=5 Participants
|
158.6 mg/dL
STANDARD_DEVIATION 42.08 • n=7 Participants
|
152.2 mg/dL
STANDARD_DEVIATION 29.15 • n=5 Participants
|
179.3 mg/dL
STANDARD_DEVIATION 40.75 • n=4 Participants
|
164.85 mg/dL
STANDARD_DEVIATION 38.4 • n=21 Participants
|
|
LDL
|
91.2 mg/dL
STANDARD_DEVIATION 29.91 • n=5 Participants
|
88.3 mg/dL
STANDARD_DEVIATION 32.22 • n=7 Participants
|
85.8 mg/dL
STANDARD_DEVIATION 21.75 • n=5 Participants
|
105.6 mg/dL
STANDARD_DEVIATION 31.67 • n=4 Participants
|
92.725 mg/dL
STANDARD_DEVIATION 28.888 • n=21 Participants
|
|
HDL
|
56.7 mg/dL
STANDARD_DEVIATION 18.85 • n=5 Participants
|
44.0 mg/dL
STANDARD_DEVIATION 16.34 • n=7 Participants
|
49.4 mg/dL
STANDARD_DEVIATION 11.14 • n=5 Participants
|
49.3 mg/dL
STANDARD_DEVIATION 15.52 • n=4 Participants
|
49.85 mg/dL
STANDARD_DEVIATION 15.463 • n=21 Participants
|
|
Triglycerides
|
107.4 ng/dL
STANDARD_DEVIATION 52.48 • n=5 Participants
|
131.3 ng/dL
STANDARD_DEVIATION 85.37 • n=7 Participants
|
85.1 ng/dL
STANDARD_DEVIATION 33.35 • n=5 Participants
|
133.0 ng/dL
STANDARD_DEVIATION 91.02 • n=4 Participants
|
114.2 ng/dL
STANDARD_DEVIATION 65.555 • n=21 Participants
|
|
Cortisol
|
2.63 ug/dL
STANDARD_DEVIATION 3.492 • n=5 Participants
|
7.08 ug/dL
STANDARD_DEVIATION 9.382 • n=7 Participants
|
1.29 ug/dL
STANDARD_DEVIATION 0.854 • n=5 Participants
|
1.07 ug/dL
STANDARD_DEVIATION 1.071 • n=4 Participants
|
3.018 ug/dL
STANDARD_DEVIATION 3.6998 • n=21 Participants
|
|
Region of Enrollment
North America
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Region of Enrollment
Europe
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Region of Enrollment
Rest of World
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeks of treatment (Week 18)Population: The ITT Analysis Set included all randomized participants regardless of Treatment Period eligibility or completion. The ITT Analysis Set was the basis for demographics, baseline characteristics, and efficacy analyses.
Assessment of dose response for change from baseline in log A4 after 12 weeks on double-blind placebo-controlled treatment (Week 18)
Outcome measures
| Measure |
Placebo
n=24 Participants
tablet
|
Tildacerfont 50 mg
n=24 Participants
50 mg
|
Tildacerfont 100 mg
n=24 Participants
100 mg
|
Tildacerfont 200 mg
n=24 Participants
200 mg
|
|---|---|---|---|---|
|
To Evaluate the Effect of Tildacerfont in Reducing A4 in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Over 12 Weeks
|
38.7 log(ng/dL)
Standard Deviation 307.38
|
-49.0 log(ng/dL)
Standard Deviation 449.02
|
147.2 log(ng/dL)
Standard Deviation 661.2
|
-10.4 log(ng/dL)
Standard Deviation 408.68
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The ITT Analysis Set included all randomized participants regardless of Treatment Period eligibility or completion. The ITT Analysis Set was the basis for demographics, baseline characteristics, and efficacy analyses.
Absolute change from baseline in A4 as determined via application of the delta theorem to the log scale analysis results after 12 weeks on double-blind, placebo-controlled treatment (Week 18). Results show mean Treatment Effect of Dose vs Placebo. A negative value represents a reduction in absolute concentration compared to baseline.
Outcome measures
| Measure |
Placebo
n=24 Participants
tablet
|
Tildacerfont 50 mg
n=23 Participants
50 mg
|
Tildacerfont 100 mg
n=24 Participants
100 mg
|
Tildacerfont 200 mg
n=24 Participants
200 mg
|
|---|---|---|---|---|
|
To Evaluate the Effect of Tildacerfont in Reducing A4 in Participants With Classic CAH Over 12 Weeks
|
0 ng/dL
Standard Error 0
|
-29.5 ng/dL
Standard Error 106.26
|
39.1 ng/dL
Standard Error 108.66
|
-23.2 ng/dL
Standard Error 107.72
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The ITT Analysis Set included all randomized participants regardless of Treatment Period eligibility or completion. The ITT Analysis Set was the basis for demographics, baseline characteristics, and efficacy analyses.
Change from baseline in A4 as assessed on the log scale after 12 weeks on double-blind, placebo-controlled treatment (Week 18). Results show mean % of Treatment Effect of Dose vs Placebo. A negative value represents a % reduction from baseline.
Outcome measures
| Measure |
Placebo
n=24 Participants
tablet
|
Tildacerfont 50 mg
n=23 Participants
50 mg
|
Tildacerfont 100 mg
n=24 Participants
100 mg
|
Tildacerfont 200 mg
n=24 Participants
200 mg
|
|---|---|---|---|---|
|
To Evaluate the Effect of Tildacerfont in Reducing A4 in Participants With Classic CAH Over 12 Weeks
|
0 percentage
Interval 0.0 to 0.0
|
-3.3 percentage
Interval -23.7 to 22.7
|
4.3 percentage
Interval -17.4 to 31.8
|
-2.6 percentage
Interval -23.3 to 23.9
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The ITT Analysis Set included all randomized participants regardless of Treatment Period eligibility or completion. The ITT Analysis Set was the basis for demographics, baseline characteristics, and efficacy analyses.
Change from baseline in 17-OHP as assessed on the log scale after 12 weeks on double-blind, placebo-controlled treatment (Week 18). A negative value represents a % reduction from baseline.
Outcome measures
| Measure |
Placebo
n=24 Participants
tablet
|
Tildacerfont 50 mg
n=20 Participants
50 mg
|
Tildacerfont 100 mg
n=22 Participants
100 mg
|
Tildacerfont 200 mg
n=20 Participants
200 mg
|
|---|---|---|---|---|
|
To Evaluate the Effect of Tildacerfont in Reducing 17-OHP in Participants With Classic CAH Over 12 Weeks
|
215.6 percent change
Standard Deviation 6165.61
|
644.2 percent change
Standard Deviation 6580.01
|
3564.6 percent change
Standard Deviation 7490.8
|
-753.7 percent change
Standard Deviation 5698.97
|
SECONDARY outcome
Timeframe: 12 weeksAbsolute change from baseline in 17-OHP as determined via application of the delta theorem to the log scale analysis results after 12 weeks on double-blind, placebo-controlled treatment (Week 18). Results show mean Treatment Effect of Dose vs Placebo. A negative value represents a reduction in absolute concentration compared to baseline.
Outcome measures
| Measure |
Placebo
n=24 Participants
tablet
|
Tildacerfont 50 mg
n=23 Participants
50 mg
|
Tildacerfont 100 mg
n=24 Participants
100 mg
|
Tildacerfont 200 mg
n=24 Participants
200 mg
|
|---|---|---|---|---|
|
To Evaluate the Effect of Tildacerfont in Reducing 17-OHP in Participants With Classic CAH Over 12 Weeks
|
0 ng/dL
Standard Error 0
|
355.9 ng/dL
Standard Error 2179.63
|
22.6 ng/dL
Standard Error 2120.47
|
-250.8 ng/dL
Standard Error 2153.59
|
Adverse Events
Period 1: Placebo
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Period 2: Part A 50 mg
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Period 2: Part A 100 mg
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Period 2: Part A 200 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Period 3: Part B 50 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Period 3: Part B 100 mg
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Period 3: Part B 200 mg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Period 4: Part C
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1: Placebo
n=24 participants at risk
Placebo
|
Period 2: Part A 50 mg
n=24 participants at risk
tildacerfont tablet administered daily via oral tablet for 12 weeks at 50 mg
|
Period 2: Part A 100 mg
n=24 participants at risk
tildacerfont tablet administered daily via oral tablet for 12 weeks at 100 mg
|
Period 2: Part A 200 mg
n=24 participants at risk
tildacerfont tablet administered daily via oral tablet for 12 weeks at 200 mg
|
Period 3: Part B 50 mg
n=1 participants at risk
Tildacerfont tablet administered daily via oral tablet for 12 weeks at 50 mg
|
Period 3: Part B 100 mg
n=44 participants at risk
Tildacerfont tablet administered daily via oral tablet for 12 weeks at 100 mg
|
Period 3: Part B 200 mg
n=41 participants at risk
Tildacerfont tablet administered daily via oral tablet for 12 weeks 200 mg
|
Period 4: Part C
n=57 participants at risk
Tildacerfont tablet administered daily via oral tablet for 46 weeks at 200 mg
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Nervous system disorders
Pyrexia
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Nervous system disorders
Status Epilepticus
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Infections and infestations
Staphylococcal Pneumonia
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Musculoskeletal and connective tissue disorders
Nasal septum deviation
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Nervous system disorders
Syncope
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
Other adverse events
| Measure |
Period 1: Placebo
n=24 participants at risk
Placebo
|
Period 2: Part A 50 mg
n=24 participants at risk
tildacerfont tablet administered daily via oral tablet for 12 weeks at 50 mg
|
Period 2: Part A 100 mg
n=24 participants at risk
tildacerfont tablet administered daily via oral tablet for 12 weeks at 100 mg
|
Period 2: Part A 200 mg
n=24 participants at risk
tildacerfont tablet administered daily via oral tablet for 12 weeks at 200 mg
|
Period 3: Part B 50 mg
n=1 participants at risk
Tildacerfont tablet administered daily via oral tablet for 12 weeks at 50 mg
|
Period 3: Part B 100 mg
n=44 participants at risk
Tildacerfont tablet administered daily via oral tablet for 12 weeks at 100 mg
|
Period 3: Part B 200 mg
n=41 participants at risk
Tildacerfont tablet administered daily via oral tablet for 12 weeks 200 mg
|
Period 4: Part C
n=57 participants at risk
Tildacerfont tablet administered daily via oral tablet for 46 weeks at 200 mg
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
20.8%
5/24 • Number of events 5 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
3.5%
2/57 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Infections and infestations
COVID-19
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
8.3%
2/24 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
7.3%
3/41 • Number of events 3 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
10.5%
6/57 • Number of events 6 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
8.3%
2/24 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
11.4%
5/44 • Number of events 5 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
17.5%
10/57 • Number of events 10 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Infections and infestations
Influenza
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
8.3%
2/24 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
3.5%
2/57 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Infections and infestations
Pharyngitis
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Infections and infestations
Viral Infection
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
General disorders
Pyrexia
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
12.5%
3/24 • Number of events 3 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
12.5%
3/24 • Number of events 3 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
6.8%
3/44 • Number of events 3 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
8.8%
5/57 • Number of events 5 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
General disorders
Asthenia
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
12.5%
3/24 • Number of events 3 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
General disorders
Fatigue
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
12.5%
3/24 • Number of events 3 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
6.8%
3/44 • Number of events 3 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
5.3%
3/57 • Number of events 3 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
General disorders
Influenza like illness
|
8.3%
2/24 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
General disorders
Chills
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
General disorders
Malaise
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
General disorders
Oedema peripheral
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
General disorders
Pain
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
3.5%
2/57 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
General disorders
Thirst
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Gastrointestinal disorders
Diarrhea
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
8.3%
2/24 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
8.3%
2/24 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.5%
2/44 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
3.5%
2/57 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
12.5%
3/24 • Number of events 3 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
12.5%
3/24 • Number of events 3 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
7.0%
4/57 • Number of events 4 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
8.3%
2/24 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Gastrointestinal disorders
Salivary gland mucocoele
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
16.7%
4/24 • Number of events 4 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
20.8%
5/24 • Number of events 5 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
8.3%
2/24 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
7.0%
4/57 • Number of events 4 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
3.5%
2/57 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Nervous system disorders
Amnesia
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Nervous system disorders
Migraine
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Nervous system disorders
Status epipticus
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
8.3%
2/24 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
12.5%
3/24 • Number of events 3 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
5.3%
3/57 • Number of events 3 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Infections and infestations
Otitis externa
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
General disorders
Temperature regulation disorder
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
6.8%
3/44 • Number of events 3 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
5.3%
3/57 • Number of events 3 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Musculoskeletal and connective tissue disorders
Anthralgia
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Musculoskeletal and connective tissue disorders
Trigger fatigue
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Psychiatric disorders
Depression
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
8.3%
2/24 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
7.0%
4/57 • Number of events 4 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.5%
2/44 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Psychiatric disorders
Depressed mood
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Psychiatric disorders
Fear of Injection
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Psychiatric disorders
Insomnia
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Psychiatric disorders
Social communication disorder
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
12.5%
3/24 • Number of events 3 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum disorder
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrom
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Vascular disorders
Hypotension
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.9%
2/41 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Vascular disorders
Hypertension
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Injury, poisoning and procedural complications
Foreign body in throat
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Investigations
Blood prolactin increased
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Investigations
Liver function test increased
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Investigations
Weight decreased
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Investigations
Blood follicle stimulating hormone decreased
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Investigations
Blood luteinising hormone decreased
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Investigations
Blood potassium decreased
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Investigations
Total bile acids increased
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Investigations
Weight increased
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Metabolism and nutrition disorders
Food Intolerance
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Metabolism and nutrition disorders
Increased apetite
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Metabolism and nutrition disorders
Tetany
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Reproductive system and breast disorders
Breast Pain
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
8.3%
2/24 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Endocrine disorders
Adrenal mass
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Endocrine disorders
Thyroiditis subacute
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
3.5%
2/57 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Nervous system disorders
Syncope
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Nervous system disorders
Tremor
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
3.5%
2/57 • Number of events 2 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Eye disorders
Visual impairment
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Renal and urinary disorders
Pollakiuria
|
4.2%
1/24 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Eye disorders
Eye Swelling
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.3%
1/44 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
2.4%
1/41 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/57 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
|
Social circumstances
Family stress
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/24 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/44 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
0.00%
0/41 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
1.8%
1/57 • Number of events 1 • 60 weeks (12 weeks Part A, 12 weeks Part B, 46 weeks Part C)
|
Additional Information
Dina Ayala-Jones, Associate Director, Clinical Development Operations
Spruce Biosciences
Phone: 424.558.1211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place