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Trial Outcomes & Findings for Dose-response Relationship Study of S42909 on Leg Ulcer Healing (NCT NCT03077165)

NCT ID: NCT03077165

Last Updated: 2020-10-08

Results Overview

Change of reference Ulcer area measurement in cm\^2 from Baseline to Week 4.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

121 participants

Primary outcome timeframe

Baseline and Week 4

Results posted on

2020-10-08

Participant Flow

Participant milestones

Participant milestones
Measure
Group A
S42909 dose 100 mg p.o., 50 mg bid S42909 100 mg: 50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Group B
S42909 dose 200 mg p.o., 100 mg bid S42909 200 mg: 50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Group C
S42909 dose 400 mg p.o., 200 mg bid S42909 400 mg: 200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Group D
S42909 dose 800 mg p.o., 400 mg bid S42909 800 mg: 200 mg Film-coated tablets per os administration,twice a day taken at the end of the morning and at evening meals.
Group E
S42909 dose 1200 mg p.o., 600 mg bid S42909 1200 mg: 200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Group F
Placebo p.o. bid Placebo Oral Tablet: Matching placebo tablets, per os administration, twice a day taken at the end of the morning and at evening meals.
Overall Study
STARTED
21
22
20
19
19
20
Overall Study
COMPLETED
20
22
20
19
16
20
Overall Study
NOT COMPLETED
1
0
0
0
3
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose-response Relationship Study of S42909 on Leg Ulcer Healing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group A
n=21 Participants
S42909 dose 100 mg p.o., 50 mg bid S42909 100 mg: 50 mg Film-coated tablets taken orally, twice a day taken at the end of the morning and at evening meals.
Group B
n=22 Participants
S42909 dose 200 mg p.o., 100 mg bid S42909 200 mg: 50 mg Film-coated tablets taken orally, twice a day taken at the end of the morning and at evening meals.
Group C
n=20 Participants
S42909 dose 400 mg p.o., 200 mg bid S42909 400 mg: 200 mg Film-coated tablets taken orally, twice a day taken at the end of the morning and at evening meals.
Group D
n=19 Participants
S42909 dose 800 mg p.o., 400 mg bid S42909 800 mg: 200 mg Film-coated tablets taken orally,twice a day taken at the end of the morning and at evening meals.
Group E
n=19 Participants
S42909 dose 1200 mg p.o., 600 mg bid S42909 1200 mg: 200 mg Film-coated tablets taken orally, twice a day taken at the end of the morning and at evening meals.
Group F
n=20 Participants
Placebo p.o. bid Placebo Oral Tablet: Matching placebo tablets taken orally, twice a day taken at the end of the morning and at evening meals.
Total
n=121 Participants
Total of all reporting groups
Age, Categorical
<=18 years
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
0 Participants
n=8 Participants
0 Participants
n=8 Participants
Age, Categorical
Between 18 and 65 years
9 Participants
n=5 Participants
12 Participants
n=7 Participants
12 Participants
n=5 Participants
4 Participants
n=4 Participants
9 Participants
n=21 Participants
11 Participants
n=8 Participants
57 Participants
n=8 Participants
Age, Categorical
>=65 years
12 Participants
n=5 Participants
10 Participants
n=7 Participants
8 Participants
n=5 Participants
15 Participants
n=4 Participants
10 Participants
n=21 Participants
9 Participants
n=8 Participants
64 Participants
n=8 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
9 Participants
n=7 Participants
10 Participants
n=5 Participants
13 Participants
n=4 Participants
14 Participants
n=21 Participants
10 Participants
n=8 Participants
66 Participants
n=8 Participants
Sex: Female, Male
Male
11 Participants
n=5 Participants
13 Participants
n=7 Participants
10 Participants
n=5 Participants
6 Participants
n=4 Participants
5 Participants
n=21 Participants
10 Participants
n=8 Participants
55 Participants
n=8 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
0 Participants
n=8 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Asian
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
0 Participants
n=8 Participants
0 Participants
n=8 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
0 Participants
n=8 Participants
0 Participants
n=8 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
0 Participants
n=8 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
White
21 Participants
n=5 Participants
22 Participants
n=7 Participants
20 Participants
n=5 Participants
19 Participants
n=4 Participants
19 Participants
n=21 Participants
20 Participants
n=8 Participants
121 Participants
n=8 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
0 Participants
n=8 Participants
0 Participants
n=8 Participants
Race (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
0 Participants
n=8 Participants
0 Participants
n=8 Participants
Region of Enrollment
Argentina
0 participants
n=5 Participants
4 participants
n=7 Participants
1 participants
n=5 Participants
2 participants
n=4 Participants
2 participants
n=21 Participants
2 participants
n=8 Participants
11 participants
n=8 Participants
Region of Enrollment
Hungary
2 participants
n=5 Participants
2 participants
n=7 Participants
1 participants
n=5 Participants
0 participants
n=4 Participants
2 participants
n=21 Participants
1 participants
n=8 Participants
8 participants
n=8 Participants
Region of Enrollment
United States
1 participants
n=5 Participants
1 participants
n=7 Participants
2 participants
n=5 Participants
1 participants
n=4 Participants
2 participants
n=21 Participants
1 participants
n=8 Participants
8 participants
n=8 Participants
Region of Enrollment
Czechia
4 participants
n=5 Participants
4 participants
n=7 Participants
4 participants
n=5 Participants
5 participants
n=4 Participants
4 participants
n=21 Participants
5 participants
n=8 Participants
26 participants
n=8 Participants
Region of Enrollment
Spain
2 participants
n=5 Participants
2 participants
n=7 Participants
1 participants
n=5 Participants
1 participants
n=4 Participants
3 participants
n=21 Participants
2 participants
n=8 Participants
11 participants
n=8 Participants
Region of Enrollment
Canada
0 participants
n=5 Participants
0 participants
n=7 Participants
1 participants
n=5 Participants
0 participants
n=4 Participants
0 participants
n=21 Participants
1 participants
n=8 Participants
2 participants
n=8 Participants
Region of Enrollment
Austria
1 participants
n=5 Participants
0 participants
n=7 Participants
0 participants
n=5 Participants
0 participants
n=4 Participants
0 participants
n=21 Participants
0 participants
n=8 Participants
1 participants
n=8 Participants
Region of Enrollment
Brazil
3 participants
n=5 Participants
3 participants
n=7 Participants
2 participants
n=5 Participants
2 participants
n=4 Participants
1 participants
n=21 Participants
2 participants
n=8 Participants
13 participants
n=8 Participants
Region of Enrollment
Poland
1 participants
n=5 Participants
0 participants
n=7 Participants
0 participants
n=5 Participants
1 participants
n=4 Participants
0 participants
n=21 Participants
0 participants
n=8 Participants
2 participants
n=8 Participants
Region of Enrollment
Italy
2 participants
n=5 Participants
2 participants
n=7 Participants
2 participants
n=5 Participants
3 participants
n=4 Participants
2 participants
n=21 Participants
2 participants
n=8 Participants
13 participants
n=8 Participants
Region of Enrollment
Slovakia
5 participants
n=5 Participants
4 participants
n=7 Participants
6 participants
n=5 Participants
4 participants
n=4 Participants
3 participants
n=21 Participants
4 participants
n=8 Participants
26 participants
n=8 Participants

PRIMARY outcome

Timeframe: Baseline and Week 4

Change of reference Ulcer area measurement in cm\^2 from Baseline to Week 4.

Outcome measures

Outcome measures
Measure
Group A
n=20 Participants
S42909 dose 100 mg p.o., 50 mg bid S42909 100 mg: 50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Group B
n=22 Participants
S42909 dose 200 mg p.o., 100 mg bid S42909 200 mg: 50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Group C
n=20 Participants
S42909 dose 400 mg p.o., 200 mg bid S42909 400 mg: 200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Group D
n=19 Participants
S42909 dose 800 mg p.o., 400 mg bid S42909 800 mg: 200 mg Film-coated tablets per os administration,twice a day taken at the end of the morning and at evening meals.
Group E
n=19 Participants
S42909 dose 1200 mg p.o., 600 mg bid S42909 1200 mg: 200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Group F
n=20 Participants
Placebo p.o. bid Placebo Oral Tablet: Matching placebo tablets, per os administration, twice a day taken at the end of the morning and at evening meals.
Relative Reduction of Reference Ulcer Area After 4 Weeks of Treatment on Top of Standard of Care Compared With Baseline Reference Ulcer Area (W000) Assessed During Study Visits
-52.85 cm2
Standard Deviation 37.79
-46.42 cm2
Standard Deviation 33.30
-31.07 cm2
Standard Deviation 38.73
-43.33 cm2
Standard Deviation 28.37
-41.10 cm2
Standard Deviation 33.99
-41.23 cm2
Standard Deviation 43.71

SECONDARY outcome

Timeframe: Up to 8 weeks

Occurring during the double-blind period of the study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 weeks

Biochemistry, Haematology and Fasting Lipids

Outcome measures

Outcome data not reported

Adverse Events

Group A

Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths

Group B

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Group C

Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths

Group D

Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths

Group E

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Group F

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Group A
n=21 participants at risk
S42909 dose 100 mg p.o., 50 mg bid S42909 100 mg: 50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Group B
n=22 participants at risk
S42909 dose 200 mg p.o., 100 mg bid S42909 200 mg: 50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Group C
n=20 participants at risk
S42909 dose 400 mg p.o., 200 mg bid S42909 400 mg: 200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Group D
n=19 participants at risk
S42909 dose 800 mg p.o., 400 mg bid S42909 800 mg: 200 mg Film-coated tablets per os administration,twice a day taken at the end of the morning and at evening meals.
Group E
n=19 participants at risk
S42909 dose 1200 mg p.o., 600 mg bid S42909 1200 mg: 200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Group F
n=20 participants at risk
Placebo p.o. bid Placebo Oral Tablet: Matching placebo tablets, per os administration, twice a day taken at the end of the morning and at evening meals.
Vascular disorders
Hypertension
4.8%
1/21 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Cardiac disorders
Atrial Fibrillation
4.8%
1/21 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Cardiac disorders
Cardiac Failure
4.8%
1/21 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Infections and infestations
Pneumonia
4.8%
1/21 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.

Other adverse events

Other adverse events
Measure
Group A
n=21 participants at risk
S42909 dose 100 mg p.o., 50 mg bid S42909 100 mg: 50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Group B
n=22 participants at risk
S42909 dose 200 mg p.o., 100 mg bid S42909 200 mg: 50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Group C
n=20 participants at risk
S42909 dose 400 mg p.o., 200 mg bid S42909 400 mg: 200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Group D
n=19 participants at risk
S42909 dose 800 mg p.o., 400 mg bid S42909 800 mg: 200 mg Film-coated tablets per os administration,twice a day taken at the end of the morning and at evening meals.
Group E
n=19 participants at risk
S42909 dose 1200 mg p.o., 600 mg bid S42909 1200 mg: 200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
Group F
n=20 participants at risk
Placebo p.o. bid Placebo Oral Tablet: Matching placebo tablets, per os administration, twice a day taken at the end of the morning and at evening meals.
Skin and subcutaneous tissue disorders
Dermatitis
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Skin and subcutaneous tissue disorders
Drug eruption
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Skin and subcutaneous tissue disorders
Eczema
9.5%
2/21 • Number of events 2 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Skin and subcutaneous tissue disorders
Pruritis
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Skin and subcutaneous tissue disorders
Blister
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Renal and urinary disorders
Haematuria
4.8%
1/21 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Renal and urinary disorders
Ureterolithiasis
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Vascular disorders
Hypertension
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
4.5%
1/22 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Vascular disorders
Pallor
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
General disorders
Chills
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
General disorders
Peripheral oedema
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Reproductive system and breast disorders
Uterine polyp
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
4.5%
1/22 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Injury, poisoning and procedural complications
Accidental overdose
4.8%
1/21 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
4.5%
1/22 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Injury, poisoning and procedural complications
Contusion
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Injury, poisoning and procedural complications
Fall
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Injury, poisoning and procedural complications
Incorrect product administration duration
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
4.5%
1/22 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Injury, poisoning and procedural complications
Overdose
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Injury, poisoning and procedural complications
Skin laceration
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Investigations
Alanine aminotransferase increased
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Investigations
Aspartate aminotransferase increased
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Investigations
Alkaline phosphatase increased
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Investigations
Blood glucose increased
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Investigations
C-reactine protein increased
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Investigations
Gamma-glutamyltrnasferase increased
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Investigations
International normalised ratio decreased
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Cardiac disorders
Atrioventricular block first degree
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretions
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Blood and lymphatic system disorders
Iron deficiency anaemia
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
4.5%
1/22 • Number of events 2 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Nervous system disorders
Dizziness
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Nervous system disorders
Headache
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
15.0%
3/20 • Number of events 4 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Nervous system disorders
somnolence
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Ear and labyrinth disorders
Tinnitus
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Gastrointestinal disorders
Abdominal pain
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 2 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Gastrointestinal disorders
Diarrhoea
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
10.5%
2/19 • Number of events 3 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
15.8%
3/19 • Number of events 4 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Gastrointestinal disorders
Food poisoning
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 2 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Gastrointestinal disorders
Pseudopolyposis
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Gastrointestinal disorders
Toothache
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Skin and subcutaneous tissue disorders
Pruritis generalized
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Skin and subcutaneous tissue disorders
Psoriasis
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
4.5%
1/22 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
4.5%
1/22 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Skin and subcutaneous tissue disorders
Rash papular
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Skin and subcutaneous tissue disorders
Skin ulcer
9.5%
2/21 • Number of events 3 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
10.0%
2/20 • Number of events 4 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 2 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Metabolism and nutrition disorders
Hyperkalemia
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Metabolism and nutrition disorders
Hyploglycemia
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Infections and infestations
Cellulitis
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Infections and infestations
Conjunctivitis bacterial
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Infections and infestations
Infected skin ulcer
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
9.1%
2/22 • Number of events 2 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
10.0%
2/20 • Number of events 2 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Infections and infestations
Nasopharyngitis
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Infections and infestations
Tonsillitis
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Infections and infestations
Urinary tract infection
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.0%
1/20 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
Infections and infestations
Urinary tract infection staphylococcal
0.00%
0/21 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/22 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/19 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
5.3%
1/19 • Number of events 1 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.
0.00%
0/20 • Adverse events were collected for each participants from the Selection visit (day -14) through end of study visit (Week 8) which is approximately during 10 weeks.

Additional Information

Monique Champagne

IlkosTherapeutic Inc.

Phone: 450-680-3381

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60