Trial Outcomes & Findings for A Study of DS-1211b in Individuals With PseudoXanthoma Elasticum (NCT NCT05569252)
NCT ID: NCT05569252
Last Updated: 2024-12-31
Results Overview
TEAEs are defined as events that start on or after the first dose of study drug or start prior to but then worsen after the first dose of study drug. Adverse events are coded using MedDRA version 26.1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
From the date of signing informed consent form up to Day 98 (14 days after last dose of study drug) post-dose of 12-week treatment period
Results posted on
2024-12-31
Participant Flow
A total of 65 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study in the United States and in the Netherlands.
Participant milestones
| Measure |
DS-1211b Low Dose
Participants who were randomized to receive DS-1211 tablets once daily for 12 weeks.
|
DS-1211b Middle Dose
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
DS-1211b High Dose
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
Placebo
Participants who were randomized to receive placebo tablets once daily for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
16
|
17
|
|
Overall Study
COMPLETED
|
15
|
16
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
DS-1211b Low Dose
Participants who were randomized to receive DS-1211 tablets once daily for 12 weeks.
|
DS-1211b Middle Dose
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
DS-1211b High Dose
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
Placebo
Participants who were randomized to receive placebo tablets once daily for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse event (central vision loss)
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of DS-1211b in Individuals With PseudoXanthoma Elasticum
Baseline characteristics by cohort
| Measure |
DS-1211b Low Dose
n=16 Participants
Participants who were randomized to receive DS-1211 tablets once daily for 12 weeks.
|
DS-1211b Middle Dose
n=16 Participants
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
DS-1211b High Dose
n=16 Participants
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
Placebo
n=17 Participants
Participants who were randomized to receive placebo tablets once daily for 12 weeks.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 7.65 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 10.84 • n=7 Participants
|
53.8 years
STANDARD_DEVIATION 8.47 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 13.92 • n=4 Participants
|
53.7 years
STANDARD_DEVIATION 10.43 • n=21 Participants
|
|
Age, Customized
<=18 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Age, Customized
≥64 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From the date of signing informed consent form up to Day 98 (14 days after last dose of study drug) post-dose of 12-week treatment periodPopulation: Treatment-emergent adverse events were assessed in the Safety Analysis Set.
TEAEs are defined as events that start on or after the first dose of study drug or start prior to but then worsen after the first dose of study drug. Adverse events are coded using MedDRA version 26.1.
Outcome measures
| Measure |
DS-1211b Low Dose
n=16 Participants
Participants who were randomized to receive DS-1211 tablets once daily for 12 weeks.
|
DS-1211b Middle Dose
n=16 Participants
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
DS-1211b High Dose
n=16 Participants
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
Placebo
n=17 Participants
Participants who were randomized to receive placebo tablets once daily for 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-1211b
Any TEAE
|
8 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-1211b
Any TEAE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-1211b
Any TEAE by maximum severity, mild
|
4 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-1211b
Any TEAE by maximum severity, moderate
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-1211b
Any TEAE by maximum severity, severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-1211b
Any serious TEAE
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-1211b
Any serious TEAE leading to drug interruption
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-1211b
Any serious TEAE leading to drug discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-1211b
Any serious TEAE related to study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-1211b
Any TEAE leading to drug interruption
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-1211b
Any TEAE leading to drug discontinuation
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-1211b
Any TEAE related to study drug
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-1211b
Any related TEAE leading to drug interruption
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-1211b
Any related TEAE leading to drug discontinuation
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-1211b
Any TEAE related to COVID-19
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Pre-dose on Days 15, 43, 84; Day 86-88 and Day 98 of 12-week treatment periodPopulation: ALP levels were assessed in participants with available data in the Biomarker Analysis Set.
ALP levels were assessed using the IFCC serum assay.
Outcome measures
| Measure |
DS-1211b Low Dose
n=16 Participants
Participants who were randomized to receive DS-1211 tablets once daily for 12 weeks.
|
DS-1211b Middle Dose
n=16 Participants
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
DS-1211b High Dose
n=16 Participants
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
Placebo
n=17 Participants
Participants who were randomized to receive placebo tablets once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Pharmacodynamic Parameter Alkaline Phosphatase (ALP) Levels
Day 15
|
17.93 percent change
Standard Deviation 10.60
|
24.39 percent change
Standard Deviation 14.45
|
39.40 percent change
Standard Deviation 11.52
|
-0.48 percent change
Standard Deviation 6.14
|
|
Percent Change From Baseline in Pharmacodynamic Parameter Alkaline Phosphatase (ALP) Levels
Day 43
|
25.02 percent change
Standard Deviation 17.54
|
42.89 percent change
Standard Deviation 30.26
|
63.48 percent change
Standard Deviation 35.68
|
-2.54 percent change
Standard Deviation 10.38
|
|
Percent Change From Baseline in Pharmacodynamic Parameter Alkaline Phosphatase (ALP) Levels
Day 84
|
25.54 percent change
Standard Deviation 16.89
|
39.81 percent change
Standard Deviation 20.19
|
61.90 percent change
Standard Deviation 37.86
|
-4.31 percent change
Standard Deviation 9.58
|
|
Percent Change From Baseline in Pharmacodynamic Parameter Alkaline Phosphatase (ALP) Levels
Day 86-88
|
16.60 percent change
Standard Deviation 18.39
|
29.93 percent change
Standard Deviation 14.61
|
49.67 percent change
Standard Deviation 26.00
|
-3.20 percent change
Standard Deviation 9.46
|
|
Percent Change From Baseline in Pharmacodynamic Parameter Alkaline Phosphatase (ALP) Levels
Day 98
|
7.65 percent change
Standard Deviation 15.34
|
9.48 percent change
Standard Deviation 14.99
|
22.95 percent change
Standard Deviation 22.42
|
-0.05 percent change
Standard Deviation 13.72
|
PRIMARY outcome
Timeframe: Pre-dose on Days 15, 43, and 84 of 12-week treatment periodPopulation: PPi levels were assessed in participants with available data in the Biomarker Analysis Set.
PPi levels were assessed from collected plasma.
Outcome measures
| Measure |
DS-1211b Low Dose
n=16 Participants
Participants who were randomized to receive DS-1211 tablets once daily for 12 weeks.
|
DS-1211b Middle Dose
n=16 Participants
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
DS-1211b High Dose
n=16 Participants
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
Placebo
n=17 Participants
Participants who were randomized to receive placebo tablets once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Pharmacodynamic Parameter Inorganic Pyrophosphate (PPi) Levels
Day 15
|
118.97 percent change
Standard Deviation 362.42
|
11.32 percent change
Standard Deviation 50.13
|
23.95 percent change
Standard Deviation 69.94
|
13.33 percent change
Standard Deviation 61.00
|
|
Percent Change From Baseline in Pharmacodynamic Parameter Inorganic Pyrophosphate (PPi) Levels
Day 43
|
17.75 percent change
Standard Deviation 50.05
|
-5.55 percent change
Standard Deviation 36.74
|
4.59 percent change
Standard Deviation 19.47
|
12.97 percent change
Standard Deviation 38.33
|
|
Percent Change From Baseline in Pharmacodynamic Parameter Inorganic Pyrophosphate (PPi) Levels
Day 84
|
23.48 percent change
Standard Deviation 78.04
|
81.77 percent change
Standard Deviation 313.08
|
24.27 percent change
Standard Deviation 97.87
|
4.28 percent change
Standard Deviation 41.45
|
PRIMARY outcome
Timeframe: Pre-dose on Days 15, 43, 84; Day 86-88 and Day 98 of 12-week treatment periodPopulation: PLP levels were assessed using Biomarker Analysis Set.
PLP levels were assessed from collected plasma.
Outcome measures
| Measure |
DS-1211b Low Dose
n=16 Participants
Participants who were randomized to receive DS-1211 tablets once daily for 12 weeks.
|
DS-1211b Middle Dose
n=16 Participants
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
DS-1211b High Dose
n=16 Participants
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
Placebo
n=17 Participants
Participants who were randomized to receive placebo tablets once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Pharmacodynamic Parameter Pyridoxal 5'-Phosphate (PLP) Levels
Day 15
|
11.01 percent change
Standard Deviation 53.93
|
45.42 percent change
Standard Deviation 92.18
|
50.97 percent change
Standard Deviation 56.78
|
3.42 percent change
Standard Deviation 36.86
|
|
Percent Change From Baseline in Pharmacodynamic Parameter Pyridoxal 5'-Phosphate (PLP) Levels
Day 43
|
8.56 percent change
Standard Deviation 42.26
|
36.73 percent change
Standard Deviation 79.89
|
25.00 percent change
Standard Deviation 48.51
|
16.25 percent change
Standard Deviation 35.09
|
|
Percent Change From Baseline in Pharmacodynamic Parameter Pyridoxal 5'-Phosphate (PLP) Levels
Day 84
|
12.03 percent change
Standard Deviation 46.95
|
53.07 percent change
Standard Deviation 110.74
|
6.04 percent change
Standard Deviation 38.72
|
-8.44 percent change
Standard Deviation 41.44
|
|
Percent Change From Baseline in Pharmacodynamic Parameter Pyridoxal 5'-Phosphate (PLP) Levels
Day 86-88
|
-5.96 percent change
Standard Deviation 27.93
|
-6.52 percent change
Standard Deviation 41.25
|
-28.76 percent change
Standard Deviation 31.72
|
-10.77 percent change
Standard Deviation 45.53
|
|
Percent Change From Baseline in Pharmacodynamic Parameter Pyridoxal 5'-Phosphate (PLP) Levels
Day 98
|
6.10 percent change
Standard Deviation 47.54
|
-10.96 percent change
Standard Deviation 45.58
|
-8.41 percent change
Standard Deviation 35.10
|
17.07 percent change
Standard Deviation 98.34
|
SECONDARY outcome
Timeframe: Day1 and Day 84 post-dose of 12-week treatment periodPopulation: Pharmacokinetic parameters were assessed using PK Analysis Set.
Pharmacokinetic parameter Cmax was estimated using population PK modeling.
Outcome measures
| Measure |
DS-1211b Low Dose
n=16 Participants
Participants who were randomized to receive DS-1211 tablets once daily for 12 weeks.
|
DS-1211b Middle Dose
n=16 Participants
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
DS-1211b High Dose
n=16 Participants
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
Placebo
Participants who were randomized to receive placebo tablets once daily for 12 weeks.
|
|---|---|---|---|---|
|
Pharmacokinetic Parameter Maximum Concentration (Cmax)
Day 1
|
252 ng/mL
Geometric Coefficient of Variation 20.5
|
540 ng/mL
Geometric Coefficient of Variation 34.8
|
713 ng/mL
Geometric Coefficient of Variation 26.9
|
—
|
|
Pharmacokinetic Parameter Maximum Concentration (Cmax)
Day 84
|
255 ng/mL
Geometric Coefficient of Variation 20.6
|
547 ng/mL
Geometric Coefficient of Variation 34.9
|
726 ng/mL
Geometric Coefficient of Variation 27.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 84 post-dose of 12-week treatment periodPopulation: Pharmacokinetic parameters were assessed using PK Analysis Set.
Pharmacokinetic parameter Tmax was assessed using population PK modeling.
Outcome measures
| Measure |
DS-1211b Low Dose
n=16 Participants
Participants who were randomized to receive DS-1211 tablets once daily for 12 weeks.
|
DS-1211b Middle Dose
n=16 Participants
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
DS-1211b High Dose
n=16 Participants
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
Placebo
Participants who were randomized to receive placebo tablets once daily for 12 weeks.
|
|---|---|---|---|---|
|
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)
Day 1
|
1.25 hours
Interval 0.75 to 2.0
|
1.13 hours
Interval 0.75 to 3.75
|
1.25 hours
Interval 0.75 to 1.75
|
—
|
|
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)
Day 84
|
1.25 hours
Interval 0.75 to 2.0
|
1.13 hours
Interval 0.75 to 3.75
|
1.25 hours
Interval 0.75 to 1.75
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 84 post-dose of 12-week treatment periodPopulation: Pharmacokinetic parameters were assessed in participants with available data in the PK Analysis Set.
Pharmacokinetic parameter Ctrough was assessed using observed concentrations at 10 hours post-dose.
Outcome measures
| Measure |
DS-1211b Low Dose
n=16 Participants
Participants who were randomized to receive DS-1211 tablets once daily for 12 weeks.
|
DS-1211b Middle Dose
n=16 Participants
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
DS-1211b High Dose
n=16 Participants
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
Placebo
Participants who were randomized to receive placebo tablets once daily for 12 weeks.
|
|---|---|---|---|---|
|
Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough)
Day 1 (10 hour)
|
17.15 ng/mL
Standard Deviation 11.58
|
26.30 ng/mL
Standard Deviation 13.71
|
48.43 ng/mL
Standard Deviation 46.50
|
—
|
|
Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough)
Day 84 (10 hour)
|
15.19 ng/mL
Standard Deviation 9.00
|
38.53 ng/mL
Standard Deviation 30.45
|
54.48 ng/mL
Standard Deviation 40.79
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 84 post-dose of 12-week treatment periodPopulation: Pharmacokinetic parameters were assessed using the PK Analysis Set.
Pharmacokinetic parameter AUCtau was assessed using population PK modeling.
Outcome measures
| Measure |
DS-1211b Low Dose
n=16 Participants
Participants who were randomized to receive DS-1211 tablets once daily for 12 weeks.
|
DS-1211b Middle Dose
n=16 Participants
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
DS-1211b High Dose
n=16 Participants
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
Placebo
Participants who were randomized to receive placebo tablets once daily for 12 weeks.
|
|---|---|---|---|---|
|
Pharmacokinetic Parameter Area Under the Plasma Concentration-time Curve (AUC)
Day 84, AUCtau
|
1020 ng*h/mL
Geometric Coefficient of Variation 29.3
|
2210 ng*h/mL
Geometric Coefficient of Variation 29.0
|
3000 ng*h/mL
Geometric Coefficient of Variation 33.7
|
—
|
|
Pharmacokinetic Parameter Area Under the Plasma Concentration-time Curve (AUC)
Day 1, AUCtau
|
978 ng*h/mL
Geometric Coefficient of Variation 28.3
|
2090 ng*h/mL
Geometric Coefficient of Variation 28.0
|
2780 ng*h/mL
Geometric Coefficient of Variation 32.1
|
—
|
Adverse Events
DS-1211b Low Dose
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
DS-1211b Middle Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
DS-1211b High Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DS-1211b Low Dose
n=16 participants at risk
Participants who were randomized to receive DS-1211 tablets once daily for 12 weeks.
|
DS-1211b Middle Dose
n=16 participants at risk
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
DS-1211b High Dose
n=16 participants at risk
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
Placebo
n=17 participants at risk
Participants who were randomized to receive placebo tablets once daily for 12 weeks.
|
|---|---|---|---|---|
|
Vascular disorders
Circulatory collapse
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
Other adverse events
| Measure |
DS-1211b Low Dose
n=16 participants at risk
Participants who were randomized to receive DS-1211 tablets once daily for 12 weeks.
|
DS-1211b Middle Dose
n=16 participants at risk
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
DS-1211b High Dose
n=16 participants at risk
Participants who were randomized to receive DS-1211b tablets once daily for 12 weeks.
|
Placebo
n=17 participants at risk
Participants who were randomized to receive placebo tablets once daily for 12 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
11.8%
2/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
5.9%
1/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Infections and infestations
COVID-19
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
5.9%
1/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Infections and infestations
Influenza
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
5.9%
1/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Musculoskeletal and connective tissue disorders
Fascitis
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
5.9%
1/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Nervous system disorders
Ophthalmic migraine
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Nervous system disorders
Tremor
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
5.9%
1/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
5.9%
1/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Eye disorders
Cataract
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Eye disorders
Central vision loss
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Investigations
Heart rate increased
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Investigations
Heart rate irregular
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Investigations
SARS CoV-2 test positive
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Cardiac disorders
Atrial flutter
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
5.9%
1/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Vascular disorders
Circulatory collapse
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Vascular disorders
Hot flush
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Ear and labyrinth disorders
Ear discomfort
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Psychiatric disorders
Depression
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
5.9%
1/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
6.2%
1/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/16 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
0.00%
0/17 • Treatment-emergent adverse events were collected from the time of signing the informed consent form up to 14 (±5) days after the last dose of study medication, up to 98 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place