Trial Outcomes & Findings for Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis (NCT NCT03760003)
NCT ID: NCT03760003
Last Updated: 2025-11-28
Results Overview
Reduction from baseline in Modified Mayo Score (MMS) MMS is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall MMS ranges from 0 to 9 where higher scores represent more severe disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
355 participants
Primary outcome timeframe
Week 8
Results posted on
2025-11-28
Participant Flow
A total of 355 patients consented to participate, 254 patients were randomized. A total of 253 patients were treated, 222 patients completed study treatment. 32 patients discontinued and 1 patient was randomized but did not receive study drug. One further patient was excluded from the Full Analysis Set (FAS) due to noncompliance with inclusion/exclusion criteria. A total of 252 patients were included in the FAS (64: ABX464 100mg q.d, 63: ABX464 50mg q.d, 61: ABX464 25mg q.d and 64: placebo).
Randomization to treatment arms was stratified by previous exposure/non-exposure to biologics and JAK inhibitors treatment use and US/non-US sites.
Participant milestones
| Measure |
ABX464 100 mg
ABX464 100 mg was administered orally (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
ABX464 50 mg was administered orally (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
ABX464 25 mg
ABX464 25 mg was administered orally (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
Matching placebo was administered orally (two capsules) once daily for 16 weeks
Two capsules of placebo once daily for 16 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
64
|
63
|
63
|
64
|
|
Overall Study
Treated
|
64
|
63
|
62
|
64
|
|
Overall Study
Full Analysis Set
|
64
|
63
|
61
|
64
|
|
Overall Study
COMPLETED
|
54
|
53
|
58
|
57
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
5
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ABX464 100 mg
n=64 Participants
ABX464 100 mg: ABX464 100mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=63 Participants
ABX464 50 mg: ABX464 50mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
ABX464 25mg
n=61 Participants
ABX464 25 mg: ABX464 25mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=64 Participants
Matching placebo will be administered orally (capsules) once daily for 16 weeks
Placebo: Two capsules of placebo once daily for 16 weeks
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=64 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=252 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=64 Participants
|
60 Participants
n=63 Participants
|
56 Participants
n=61 Participants
|
60 Participants
n=64 Participants
|
237 Participants
n=252 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=64 Participants
|
3 Participants
n=63 Participants
|
5 Participants
n=61 Participants
|
4 Participants
n=64 Participants
|
15 Participants
n=252 Participants
|
|
Age, Continuous
|
42.2 Years
STANDARD_DEVIATION 12.34 • n=64 Participants
|
40.2 Years
STANDARD_DEVIATION 13.94 • n=63 Participants
|
41.5 Years
STANDARD_DEVIATION 14.16 • n=61 Participants
|
41.1 Years
STANDARD_DEVIATION 14.43 • n=64 Participants
|
41.2 Years
STANDARD_DEVIATION 13.67 • n=252 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=64 Participants
|
36 Participants
n=63 Participants
|
21 Participants
n=61 Participants
|
24 Participants
n=64 Participants
|
104 Participants
n=252 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=64 Participants
|
27 Participants
n=63 Participants
|
40 Participants
n=61 Participants
|
40 Participants
n=64 Participants
|
148 Participants
n=252 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Hungary
|
5 participants
n=64 Participants
|
5 participants
n=63 Participants
|
5 participants
n=61 Participants
|
7 participants
n=64 Participants
|
22 participants
n=252 Participants
|
|
Region of Enrollment
Czechia
|
2 participants
n=64 Participants
|
6 participants
n=63 Participants
|
4 participants
n=61 Participants
|
2 participants
n=64 Participants
|
14 participants
n=252 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=64 Participants
|
1 participants
n=63 Participants
|
0 participants
n=61 Participants
|
1 participants
n=64 Participants
|
2 participants
n=252 Participants
|
|
Region of Enrollment
Ukraine
|
12 participants
n=64 Participants
|
7 participants
n=63 Participants
|
6 participants
n=61 Participants
|
7 participants
n=64 Participants
|
32 participants
n=252 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=64 Participants
|
0 participants
n=63 Participants
|
0 participants
n=61 Participants
|
0 participants
n=64 Participants
|
1 participants
n=252 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=64 Participants
|
1 participants
n=63 Participants
|
2 participants
n=61 Participants
|
1 participants
n=64 Participants
|
5 participants
n=252 Participants
|
|
Region of Enrollment
Austria
|
1 participants
n=64 Participants
|
1 participants
n=63 Participants
|
1 participants
n=61 Participants
|
3 participants
n=64 Participants
|
6 participants
n=252 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=64 Participants
|
2 participants
n=63 Participants
|
0 participants
n=61 Participants
|
2 participants
n=64 Participants
|
8 participants
n=252 Participants
|
|
Region of Enrollment
Poland
|
16 participants
n=64 Participants
|
16 participants
n=63 Participants
|
18 participants
n=61 Participants
|
20 participants
n=64 Participants
|
70 participants
n=252 Participants
|
|
Region of Enrollment
Italy
|
5 participants
n=64 Participants
|
2 participants
n=63 Participants
|
6 participants
n=61 Participants
|
7 participants
n=64 Participants
|
20 participants
n=252 Participants
|
|
Region of Enrollment
Slovakia
|
3 participants
n=64 Participants
|
7 participants
n=63 Participants
|
5 participants
n=61 Participants
|
3 participants
n=64 Participants
|
18 participants
n=252 Participants
|
|
Region of Enrollment
Slovenia
|
1 participants
n=64 Participants
|
1 participants
n=63 Participants
|
1 participants
n=61 Participants
|
0 participants
n=64 Participants
|
3 participants
n=252 Participants
|
|
Region of Enrollment
France
|
8 participants
n=64 Participants
|
8 participants
n=63 Participants
|
7 participants
n=61 Participants
|
7 participants
n=64 Participants
|
30 participants
n=252 Participants
|
|
Region of Enrollment
Serbia
|
0 participants
n=64 Participants
|
3 participants
n=63 Participants
|
2 participants
n=61 Participants
|
0 participants
n=64 Participants
|
5 participants
n=252 Participants
|
|
Region of Enrollment
Germany
|
5 participants
n=64 Participants
|
3 participants
n=63 Participants
|
4 participants
n=61 Participants
|
4 participants
n=64 Participants
|
16 participants
n=252 Participants
|
|
Baseline Modified Mayo Score (MMS)
Baseline MMS: 4
|
0 Participants
n=64 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=61 Participants
|
1 Participants
n=64 Participants
|
1 Participants
n=252 Participants
|
|
Baseline Modified Mayo Score (MMS)
Baseline MMS: 5 to 6
|
17 Participants
n=64 Participants
|
16 Participants
n=63 Participants
|
17 Participants
n=61 Participants
|
21 Participants
n=64 Participants
|
71 Participants
n=252 Participants
|
|
Baseline Modified Mayo Score (MMS)
Baseline MMS: 7 to 9
|
47 Participants
n=64 Participants
|
47 Participants
n=63 Participants
|
44 Participants
n=61 Participants
|
42 Participants
n=64 Participants
|
180 Participants
n=252 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Number of patients in the category with data available for baseline and the respective visit.
Reduction from baseline in Modified Mayo Score (MMS) MMS is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall MMS ranges from 0 to 9 where higher scores represent more severe disease.
Outcome measures
| Measure |
ABX464 25 mg
n=59 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=60 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=58 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=54 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Reduction From Baseline in Modified Mayo Score (MMS) at Week 8
|
-3.1 Score
Interval -3.6 to -2.6
|
-1.9 Score
Interval -2.4 to -1.5
|
-2.9 Score
Interval -3.4 to -2.5
|
-3.2 Score
Interval -3.7 to -2.7
|
SECONDARY outcome
Timeframe: Week 16Population: Number of patients in the category with data available for baseline and the respective visit.
Reduction from baseline in Modified Mayo Score (MMS) MMS is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall MMS ranges from 0 to 9 where higher scores represent more severe disease.
Outcome measures
| Measure |
ABX464 25 mg
n=37 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=46 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=31 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=30 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Reduction From Baseline in MMS at Week 16
Overall
|
-3.3 Score
Interval -3.9 to -2.7
|
-2.4 Score
Interval -2.9 to -1.8
|
-3.6 Score
Interval -4.3 to -2.9
|
-3.2 Score
Interval -3.9 to -2.5
|
|
Reduction From Baseline in MMS at Week 16
With Previous Biologics or JAK Inhibitors Exposure
|
-2.9 Score
Interval -3.7 to -2.1
|
-1.3 Score
Interval -2.0 to -0.5
|
-3.3 Score
Interval -4.1 to -2.6
|
-3.0 Score
Interval -3.9 to -2.1
|
|
Reduction From Baseline in MMS at Week 16
Without Previous Biologics or JAK Inhibitors Exposure
|
-3.7 Score
Interval -4.6 to -2.8
|
-3.4 Score
Interval -4.2 to -2.6
|
-3.6 Score
Interval -4.8 to -2.3
|
-3.4 Score
Interval -4.4 to -2.5
|
SECONDARY outcome
Timeframe: Week 8Population: Full analysis set
Number of participants who achieved clinical remission per Modified Mayo Score at Week 8 MMS is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall MMS ranges from 0 to 9 where higher scores represent more severe disease. Clinical remission is defined as SFS ≤ 1, RBS of 0, and endoscopic subscore ≤ 1 (modified to exclude friability)
Outcome measures
| Measure |
ABX464 25 mg
n=61 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=64 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=64 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=63 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Number of Participants in Clinical Remission Per MMS at Week 8
|
16 Participants
|
8 Participants
|
16 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Number of patients in the category with data available for baseline and the respective visit.
Number of participants who achieved clinical remission per Modified Mayo Score at Week 16 MMS is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall MMS ranges from 0 to 9 where higher scores represent more severe disease. Clinical remission is defined as SFS ≤ 1, RBS of 0, and endoscopic subscore ≤ 1 (modified to exclude friability)
Outcome measures
| Measure |
ABX464 25 mg
n=37 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=46 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=31 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=30 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Number of Participants in Clinical Remission Per MMS at Week 16
|
9 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full analysis set
Clinical response is defined as a reduction in MMS of at least 2 points and greater than or equal to 30 percent from baseline with an accompanying decrease in rectal bleeding sub-score of greater than or equal to 1 point or absolute rectal bleeding sub-score of less than or equal to 1 point.
Outcome measures
| Measure |
ABX464 25 mg
n=61 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=64 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=64 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=63 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Number of Participants With Clinical Response at Week 8
|
38 Participants
|
22 Participants
|
32 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Number of patients in the category with data available for baseline and the respective visit.
Clinical response is defined as a reduction in MMS of at least 2 points and greater than or equal to 30 percent from baseline with an accompanying decrease in rectal bleeding sub-score of greater than or equal to 1 point or absolute rectal bleeding sub-score of less than or equal to 1 point.
Outcome measures
| Measure |
ABX464 25 mg
n=37 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=46 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=31 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=30 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Number of Participants With Clinical Response at Week 16
|
25 Participants
|
20 Participants
|
19 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Number of patients in the category with data available for baseline and the respective visit.
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1 (excluding friability) Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1. = Mild disease (erythema, decreased vascular pattern); 2. = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3. = Severe disease (spontaneous bleeding, ulceration). A higher endoscopic score indicates more severe disease.
Outcome measures
| Measure |
ABX464 25 mg
n=58 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=59 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=54 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=53 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Number of Participants With Endoscopic Improvement at Week 8
|
20 Participants
|
8 Participants
|
24 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Number of patients in the category with data available for baseline and the respective visit.
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1 (excluding friability) Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1. = Mild disease (erythema, decreased vascular pattern); 2. = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3. = Severe disease (spontaneous bleeding, ulceration). A higher endoscopic score indicates more severe disease.
Outcome measures
| Measure |
ABX464 25 mg
n=38 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=46 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=32 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=31 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Number of Participants With Endoscopic Improvement at Week 16
|
11 Participants
|
9 Participants
|
11 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full analysis set
Mucosal healing is defined as endoscopic remission (overall mucosal appearance at endoscopy subscore=0) and histological remission (Geboes score \<2.0 based on rectal biopsy). The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration). The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration. A higher score is associated with higher disease activity.
Outcome measures
| Measure |
ABX464 25 mg
n=61 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=64 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=64 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=63 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Number of Participants With Mucosal Healing at Week 8
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Full analysis set.
Mucosal healing is defined as endoscopic remission (overall mucosal appearance at endoscopy subscore=0) and histological remission (Geboes score \<2.0 based on rectal biopsy). The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration). The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration. A higher score is associated with higher disease activity.
Outcome measures
| Measure |
ABX464 25 mg
n=61 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=64 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=64 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=63 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Number of Participants With Mucosal Healing at Week 16
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 8, Day 29, Day 57, Day 85, Day 113, and Day 120 (End of Study)Population: Patients in the category relative to the number of patients in the relevant analysis set and treatment group with data available
Participants recorded stool frequency using an electronic subject diary on a daily basis. The stool frequency subscore (SFS) ranges from 0 to 3 according to the following scale: Score 0: Normal number of stools Score 1: 1 to 2 stools per day more than normal Score 2: 3 to 4 stools per day more than normal Score 3: 5 or more stools per day more than normal Decreasing score indicates improvement.
Outcome measures
| Measure |
ABX464 25 mg
n=61 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=64 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=64 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=63 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Number of Participants With Reduction of Stool Frequency Relative to Baseline (Day 1)
Day 29
|
35 Participants
|
26 Participants
|
34 Participants
|
36 Participants
|
|
Number of Participants With Reduction of Stool Frequency Relative to Baseline (Day 1)
Week 8 (Day 57)
|
39 Participants
|
37 Participants
|
39 Participants
|
37 Participants
|
|
Number of Participants With Reduction of Stool Frequency Relative to Baseline (Day 1)
Day 8
|
14 Participants
|
12 Participants
|
18 Participants
|
22 Participants
|
|
Number of Participants With Reduction of Stool Frequency Relative to Baseline (Day 1)
Day 85
|
37 Participants
|
30 Participants
|
41 Participants
|
39 Participants
|
|
Number of Participants With Reduction of Stool Frequency Relative to Baseline (Day 1)
Week 16 (Day 113)
|
42 Participants
|
38 Participants
|
44 Participants
|
39 Participants
|
|
Number of Participants With Reduction of Stool Frequency Relative to Baseline (Day 1)
End of study (Day 120)
|
1 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 8, Day 29, Day 57, Day 85, Day 113, and Day 120 (End of Study)Population: Number of participants in the relevant analysis set and treatment group with data available.
Participants recorded rectal bleeding in an electronic subject diary on a daily basis. Rectal bleeding score (RBS) is taken as the worst subscore of the three most recent scores within 7 days prior to the visit. The rectal bleeding subscore ranges from 0 to 3 according to the following scale: Score 0: No blood seen Score 1: Streaks of blood with stool less than half the time Score 2: Obvious blood with stool most of the time Score 3: Blood alone passed A lower score represents an improvement in rectal bleeding.
Outcome measures
| Measure |
ABX464 25 mg
n=60 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=64 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=63 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=61 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Number of Participants With Reduction of Rectal Bleeding Frequency Relative to Baseline
Day 8
|
24 Participants
|
16 Participants
|
25 Participants
|
23 Participants
|
|
Number of Participants With Reduction of Rectal Bleeding Frequency Relative to Baseline
Day 29
|
39 Participants
|
24 Participants
|
44 Participants
|
38 Participants
|
|
Number of Participants With Reduction of Rectal Bleeding Frequency Relative to Baseline
Week 8 (Day 57)
|
46 Participants
|
33 Participants
|
48 Participants
|
44 Participants
|
|
Number of Participants With Reduction of Rectal Bleeding Frequency Relative to Baseline
Day 85
|
44 Participants
|
35 Participants
|
47 Participants
|
39 Participants
|
|
Number of Participants With Reduction of Rectal Bleeding Frequency Relative to Baseline
Week 16 (Day 113)
|
46 Participants
|
37 Participants
|
50 Participants
|
45 Participants
|
|
Number of Participants With Reduction of Rectal Bleeding Frequency Relative to Baseline
End of study (Day 120)
|
1 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 8, Day 29, Day 57, Day 85, Day 113, and Day 120 (End of Study)Population: Reduction in least squares mean pMMS for all treatment groups at each visit
Partial Modified Mayo Score (pMMS) Change from baseline The pMMS is a composite score of UC disease activity based on the following 2 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools per day) to 3 (5 or more stools per day more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). The overall pMMS score ranges from 0 to 6 with higher scores representing more severe disease.
Outcome measures
| Measure |
ABX464 25 mg
n=61 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=64 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=64 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=63 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Partial Modified Mayo Score Change From Baseline
Day 8
|
-0.7 Score
Interval -1.0 to -0.4
|
-0.4 Score
Interval -0.7 to -0.1
|
-0.7 Score
Interval -1.0 to -0.3
|
-0.8 Score
Interval -1.1 to -0.4
|
|
Partial Modified Mayo Score Change From Baseline
Day 29
|
-1.8 Score
Interval -2.1 to -1.4
|
-0.9 Score
Interval -1.3 to -0.6
|
-1.8 Score
Interval -2.1 to -1.5
|
-1.8 Score
Interval -2.2 to -1.5
|
|
Partial Modified Mayo Score Change From Baseline
Week 8 (Day 57)
|
-2.3 Score
Interval -2.6 to -2.0
|
-1.6 Score
Interval -1.9 to -1.3
|
-2.2 Score
Interval -2.6 to -1.9
|
-2.2 Score
Interval -2.5 to -1.9
|
|
Partial Modified Mayo Score Change From Baseline
Day 85
|
-2.3 Score
Interval -2.7 to -2.0
|
-1.6 Score
Interval -1.9 to -1.3
|
-2.4 Score
Interval -2.8 to -2.1
|
-2.3 Score
Interval -2.6 to -2.0
|
|
Partial Modified Mayo Score Change From Baseline
Week 16 (Day 113)
|
-2.6 Score
Interval -3.0 to -2.3
|
-2.0 Score
Interval -2.3 to -1.7
|
-2.8 Score
Interval -3.1 to -2.4
|
-2.4 Score
Interval -2.8 to -2.1
|
|
Partial Modified Mayo Score Change From Baseline
End of Study (Day 120)
|
-3.3 Score
Interval -5.7 to -0.9
|
-1.2 Score
Interval -2.9 to 0.5
|
-1.1 Score
Interval -2.1 to -0.2
|
-1.9 Score
Interval -2.9 to -1.0
|
SECONDARY outcome
Timeframe: Week 8 and Week 16Population: Number of patients in the relevant analysis set and treatment group, with non-missing values of the parameter
Fecal Calprotectin (FC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. FC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. Outcome will be measured based on a reduction in FC relative to baseline values.
Outcome measures
| Measure |
ABX464 25 mg
n=52 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=52 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=44 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=45 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Number of Participants With Reduction Relative to Baseline in Fecal Calprotectin at Weeks 8 and 16
Week 16
|
37 Participants
|
22 Participants
|
37 Participants
|
35 Participants
|
|
Number of Participants With Reduction Relative to Baseline in Fecal Calprotectin at Weeks 8 and 16
Week 8
|
33 Participants
|
26 Participants
|
33 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Week 8 and Week 16Population: Number of patients in the relevant analysis set and treatment group, with non-missing values of the parameter
CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. CRP has a short half-life (19 hours) and therefore rises early after the onset of inflammation and rapidly decreases after resolution of the inflammation. It is induced by interleukin-6, TNF-alpha and other pro-inflammatory cytokines that are produced within the intestinal lamina propria. Outcome will be measured based on a reduction in CRP relative to baseline values.
Outcome measures
| Measure |
ABX464 25 mg
n=58 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=58 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=58 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=48 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Number of Participants With Reduction Relative to Baseline in C Reactive Protein at Weeks 8 and 16
Week 8 (Day 57)
|
39 Participants
|
29 Participants
|
31 Participants
|
28 Participants
|
|
Number of Participants With Reduction Relative to Baseline in C Reactive Protein at Weeks 8 and 16
Week 16 (Day 113)
|
37 Participants
|
29 Participants
|
31 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Week 8 and Week 16Population: Only samples which were collected have been analyzed
Absolute quantification (QuantaSoft Pro) of the miR-124 copy number was performed at Week 8 and Week 16 using droplet digital PCR technology (ddPCR) on whole blood samples. "0" in the placebo column means "no signal", so BLQ (Below the level of quantification).
Outcome measures
| Measure |
ABX464 25 mg
n=56 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=60 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=57 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=50 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
miRNA-124 Expression (Copy Number) in Whole Blood at Week 8 and Week 16
Week 16
|
4154 copies number/cell
Standard Deviation 5273
|
23.79 copies number/cell
Standard Deviation 94.69
|
13268 copies number/cell
Standard Deviation 11134
|
7723 copies number/cell
Standard Deviation 7477
|
|
miRNA-124 Expression (Copy Number) in Whole Blood at Week 8 and Week 16
Week 8
|
4598 copies number/cell
Standard Deviation 11348
|
28.93 copies number/cell
Standard Deviation 146.4
|
13753 copies number/cell
Standard Deviation 12142
|
8517 copies number/cell
Standard Deviation 6252
|
SECONDARY outcome
Timeframe: Day 1Population: Only samples which were collected have been analyzed
Serum samples from participants who received ABX464 (25, 50 or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57, and Day 113). IL6 was measured using the 8-plex assay on the ELLA Platform (Biotechne). All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline IL-6 values - Day 1 IL-6 values/Day 1 IL-6 values)\*100
Outcome measures
| Measure |
ABX464 25 mg
n=60 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=64 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=62 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=61 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
IL-6 Serum Concentrations
|
100 Percentage of IL-6
Standard Error 19.37
|
100 Percentage of IL-6
Standard Error 28.77
|
100 Percentage of IL-6
Standard Error 10.77
|
100 Percentage of IL-6
Standard Error 13.36
|
SECONDARY outcome
Timeframe: Week 8Population: Number of participants with data for endoscopy relative to the number of patients in the relevant analysis set
Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1. = Mild disease (erythema, decreased vascular pattern); 2. = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3. = Severe disease (spontaneous bleeding, ulceration). A higher score represents more severe disease.
Outcome measures
| Measure |
ABX464 25 mg
n=58 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=59 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=54 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=53 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Number of Participants With Endoscopic Remission at Week 8
|
4 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Number of patients in the category with data available for baseline and the respective visit.
Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1. = Mild disease (erythema, decreased vascular pattern); 2. = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3. = Severe disease (spontaneous bleeding, ulceration). A higher score represents more severe disease.
Outcome measures
| Measure |
ABX464 25 mg
n=38 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=46 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=32 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=31 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Number of Participants With Endoscopic Remission at Week 16
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Only samples which were collected have been analyzed
Serum samples from patients who received ABX464 (25, 50 or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57, and Day 113). IL10 was measured using the 8-plex assay on the ELLA Platform. All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline IL-10 values - Day 1 IL-10 values/Day 1 IL-10 values)\*100
Outcome measures
| Measure |
ABX464 25 mg
n=60 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=64 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=62 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=61 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
IL-10 Serum Concentrations
|
100 Percentage of IL-10
Standard Error 18.98
|
100 Percentage of IL-10
Standard Error 17.54
|
100 Percentage of IL-10
Standard Error 8.982
|
100 Percentage of IL-10
Standard Error 6.989
|
SECONDARY outcome
Timeframe: Day 1Population: Only samples which were collected have been analyzed
Serum samples from patients who received ABX464 (25, 50, or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57 and Day 113). IL1beta was measured using the 8-plex assay on the ELLA Platform. All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline IL-1B values - Day 1 IL-1B values/Day 1 IL-1B values)\*100
Outcome measures
| Measure |
ABX464 25 mg
n=61 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=64 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=62 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=62 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
IL-1B Serum Concentrations
|
100 Percentage of IL-1B
Standard Error 7.043
|
100 Percentage of IL-1B
Standard Error 4.87
|
100 Percentage of IL-1B
Standard Error 6.514
|
100 Percentage of IL-1B
Standard Error 8.988
|
SECONDARY outcome
Timeframe: Day 1Population: Only samples which were collected have been analyzed
Serum samples from patients who received ABX464 (25, 50, or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57 and Day 113 TNF-alpha was measured using the 8-plex assay on the ELLA Platform. All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline TNFα values - Day 1 TNFα values/Day 1 TNFα values)\*100
Outcome measures
| Measure |
ABX464 25 mg
n=60 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=64 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=62 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=62 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
TNFα Serum Concentrations
|
100 Percentage of TNFα
Standard Error 19
|
100 Percentage of TNFα
Standard Error 5.473
|
100 Percentage of TNFα
Standard Error 18.79
|
100 Percentage of TNFα
Standard Error 9.313
|
SECONDARY outcome
Timeframe: Week 8 and Week 16Population: Only samples which were collected have been analyzed. Patients that were evaluated with an endoscopy at week 16 are the subset of patients that did not achieve endoscopic improvement at week 8
Infiltrate/Histopathology (Rectal/Sigmoidal Biopsies) using the Robarts Histopathology Index (RHI) Week 8 and Week 16 biopsies will be compared to biopsies at baseline to assess the disease evolution at a tissue level, based on the Robarts Histological Index. The score ranges from 0 (no disease activity) to 33 (severe disease activity) is based on evaluation of 4 parameters: chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in the epithelium and erosion and ulceration. A higher score indicates more severe disease.
Outcome measures
| Measure |
ABX464 25 mg
n=49 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=52 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=44 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=44 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Infiltrate/Histopathology Using Robarts Histopathology Index (RHI) at Week 8 and Week 16
Week 8
|
-7.3 score on a scale
Interval -9.7 to -4.9
|
-3.4 score on a scale
Interval -5.8 to -1.0
|
-7.3 score on a scale
Interval -9.9 to -4.8
|
-5.9 score on a scale
Interval -8.5 to -3.3
|
|
Change From Baseline in Infiltrate/Histopathology Using Robarts Histopathology Index (RHI) at Week 8 and Week 16
Week 16
|
-8.0 score on a scale
Interval -11.2 to -4.7
|
-2.8 score on a scale
Interval -5.9 to 0.3
|
-7.6 score on a scale
Interval -11.2 to -4.0
|
-5.8 score on a scale
Interval -10.0 to -1.6
|
SECONDARY outcome
Timeframe: Week 8 and Week 16Population: Only samples which were collected have been analyzed and included baseline and data for week 8 or week 16. Patients that were evaluated with an endoscopy at week 16 are the subset of patients that did not achieve endoscopic improvement at week 8
The Geboes score is composed of 6 major grades that assess different aspects of the biopsy findings, with each grade having its own score range: 1. Structural Changes (Grade 0): Range: 0 (No changes) to 3 (Severe changes) 2. Chronic Inflammation (Grade 1): Range: 0 (No inflammation) to 3 (Severe inflammation) 3. Lamina Propria Neutrophils (Grade 2): Range: 0 (None) to 3 (Severe infiltration of neutrophils) 4. Neutrophils in the Epithelium (Grade 3): Range: 0 (None) to 3 (Severe neutrophil infiltration) 5. Crypt Destruction (Grade 4): Range: 0 (No destruction) to 3 (Severe crypt destruction) 6. Erosion and Ulcers (Grade 5): Range: 0 (None) to 3 (Severe erosion/ulceration) Subscales are summed across all 6 grades, final total score between 0 and 18 : * 0-5: Minimal or no inflammation * 6-10: Mild inflammation * 11-15: Moderate inflammation * 16-18: Severe inflammation or damage A higher score indicates more severe disease
Outcome measures
| Measure |
ABX464 25 mg
n=49 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=52 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=44 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=44 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Infiltrate/Histopathology - Geboes Score at Week 8 and Week 16
Week 8
|
-4.1 Score change from baseline
Interval -5.6 to -2.7
|
-1.9 Score change from baseline
Interval -3.4 to -0.5
|
-4.8 Score change from baseline
Interval -6.3 to -3.3
|
-3.3 Score change from baseline
Interval -4.9 to -1.8
|
|
Change From Baseline in Infiltrate/Histopathology - Geboes Score at Week 8 and Week 16
Week 16
|
-4.7 Score change from baseline
Interval -6.6 to -2.8
|
-1.3 Score change from baseline
Interval -3.1 to 0.5
|
-4.4 Score change from baseline
Interval -6.5 to -2.3
|
-3.9 Score change from baseline
Interval -6.3 to -1.5
|
SECONDARY outcome
Timeframe: Day 8, Day 29, Day 57, and Day 113Population: Only samples which were collected have been analyzed
Serum samples from participants who received ABX464 (25, 50 or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57, and Day 113). IL6 was measured using the 8-plex assay on the ELLA Platform (Biotechne). All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline IL-6 values - Day 1 IL-6 values/Day 1 IL-6 values)\*100
Outcome measures
| Measure |
ABX464 25 mg
n=60 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=64 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=62 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=61 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
IL-6 Serum Concentrations
Day 8
|
103.6 Percent Change
Standard Error 8.641
|
132.7 Percent Change
Standard Error 15.18
|
166.4 Percent Change
Standard Error 20.98
|
96.45 Percent Change
Standard Error 9.034
|
|
IL-6 Serum Concentrations
Day 29
|
89.31 Percent Change
Standard Error 8.608
|
128.2 Percent Change
Standard Error 10.85
|
117 Percent Change
Standard Error 10.92
|
93.36 Percent Change
Standard Error 12.19
|
|
IL-6 Serum Concentrations
Week 8 (Day 57)
|
89.75 Percent Change
Standard Error 8.662
|
125.7 Percent Change
Standard Error 17.11
|
118.9 Percent Change
Standard Error 11.3
|
150.6 Percent Change
Standard Error 47.06
|
|
IL-6 Serum Concentrations
Week 16 (Day 113)
|
98.29 Percent Change
Standard Error 12.03
|
131.8 Percent Change
Standard Error 16.97
|
108.3 Percent Change
Standard Error 14.23
|
170.1 Percent Change
Standard Error 56.4
|
SECONDARY outcome
Timeframe: Day 8, Day 29, Week 8 and Week 16Population: Only samples which were collected have been analyzed
Serum samples from patients who received ABX464 (25, 50 or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57, and Day 113). IL10 was measured using the 8-plex assay on the ELLA Platform. All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline IL-10 values - Day 1 IL-10 values/Day 1 IL-10 values)\*100
Outcome measures
| Measure |
ABX464 25 mg
n=60 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=64 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=62 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=61 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
IL-10 Serum Concentrations
Day 8
|
101 Percent Change
Standard Error 4.288
|
100.1 Percent Change
Standard Error 3.918
|
100.3 Percent Change
Standard Error 4.596
|
102.3 Percent Change
Standard Error 5.827
|
|
IL-10 Serum Concentrations
Day 29
|
91.40 Percent Change
Standard Error 4.519
|
102.5 Percent Change
Standard Error 4.728
|
98.71 Percent Change
Standard Error 6.626
|
87.22 Percent Change
Standard Error 3.638
|
|
IL-10 Serum Concentrations
Week 8 (Day 57)
|
89.30 Percent Change
Standard Error 4.289
|
94.18 Percent Change
Standard Error 4.886
|
96.00 Percent Change
Standard Error 5.590
|
99.30 Percent Change
Standard Error 7.431
|
|
IL-10 Serum Concentrations
Week 16 (Day 113)
|
91.24 Percent Change
Standard Error 4.911
|
91.85 Percent Change
Standard Error 5.943
|
103.9 Percent Change
Standard Error 7.435
|
92.50 Percent Change
Standard Error 4.879
|
SECONDARY outcome
Timeframe: Day 8, Day 29, Day 57 and Day 113Population: Only samples which were collected have been analyzed
Serum samples from patients who received ABX464 (25, 50, or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57 and Day 113). IL1beta was measured using the 8-plex assay on the ELLA Platform. All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline IL-1B values - Day 1 IL-1B values/Day 1 IL-1B values)\*100
Outcome measures
| Measure |
ABX464 25 mg
n=61 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=64 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=62 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=62 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
IL-1B Serum Concentrations
Day 8
|
103.7 Percent Change
Standard Error 5.562
|
111 Percent Change
Standard Error 5.203
|
102.8 Percent Change
Standard Error 7.453
|
118.2 Percent Change
Standard Error 10.44
|
|
IL-1B Serum Concentrations
Day 29
|
138 Percent Change
Standard Error 41.41
|
112.6 Percent Change
Standard Error 7.052
|
115 Percent Change
Standard Error 9.424
|
101.3 Percent Change
Standard Error 5.435
|
|
IL-1B Serum Concentrations
Week 8 (Day 57)
|
99 Percent Change
Standard Error 6.605
|
124.1 Percent Change
Standard Error 12.24
|
105.3 Percent Change
Standard Error 5.735
|
100.3 Percent Change
Standard Error 6.49
|
|
IL-1B Serum Concentrations
Week 16 (Day 113)
|
124.1 Percent Change
Standard Error 12.24
|
109 Percent Change
Standard Error 7.042
|
102.4 Percent Change
Standard Error 6.513
|
137.5 Percent Change
Standard Error 26.11
|
SECONDARY outcome
Timeframe: Day 8, Day 29, Day 57 and Day 113Population: Only samples which were collected have been analyzed
Serum samples from patients who received ABX464 (25, 50, or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57 and Day 113 TNF-alpha was measured using the 8-plex assay on the ELLA Platform. All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline TNFα values - Day 1 TNFα values/Day 1 TNFα values)\*100
Outcome measures
| Measure |
ABX464 25 mg
n=60 Participants
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=64 Participants
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks
|
ABX464 100 mg
n=62 Participants
ABX464 100 mg: ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464 50 mg
n=62 Participants
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
|
|---|---|---|---|---|
|
TNFα Serum Concentrations
Day 8
|
96.42 Percent Change
Standard Error 4.552
|
99.7 Percent Change
Standard Error 2.739
|
98.8 Percent Change
Standard Error 3.423
|
96.77 Percent Change
Standard Error 5.844
|
|
TNFα Serum Concentrations
Day 29
|
92.64 Percent Change
Standard Error 4.629
|
110.2 Percent Change
Standard Error 10.12
|
99.62 Percent Change
Standard Error 5.374
|
91.30 Percent Change
Standard Error 4.676
|
|
TNFα Serum Concentrations
Week 8 (Day 57)
|
97.51 Percent Change
Standard Error 4.874
|
102.6 Percent Change
Standard Error 4.873
|
105.5 Percent Change
Standard Error 9.675
|
95.55 Percent Change
Standard Error 4.503
|
|
TNFα Serum Concentrations
Week 16 (Day 113)
|
100.1 Percent Change
Standard Error 7.194
|
111.4 Percent Change
Standard Error 7.725
|
103.7 Percent Change
Standard Error 7.610
|
108.6 Percent Change
Standard Error 10.61
|
Adverse Events
ABX464, 100mg
Serious events: 4 serious events
Other events: 45 other events
Deaths: 0 deaths
ABX464, 50 mg
Serious events: 4 serious events
Other events: 38 other events
Deaths: 0 deaths
ABX464, 25mg
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABX464, 100mg
n=64 participants at risk
ABX464 100mg: ABX464 100mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464, 50 mg
n=63 participants at risk
ABX464 50mg: ABX464 50mg (One capsule of ABX464 50 mg + One capsule of placebo) once daily for 16 weeks
|
ABX464, 25mg
n=62 participants at risk
ABX464 25mg: ABX464 25mg (One capsule of ABX464 25 mg + One capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=64 participants at risk
Matching placebo will be adminstrated orally (Capsules) and daily for 16 weeks
Placebo: Two capsules of placebo once daily for 16 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
4.7%
3/64 • Number of events 3 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydratation
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
Other adverse events
| Measure |
ABX464, 100mg
n=64 participants at risk
ABX464 100mg: ABX464 100mg (two capsules of ABX464 50 mg) once daily for 16 weeks
|
ABX464, 50 mg
n=63 participants at risk
ABX464 50mg: ABX464 50mg (One capsule of ABX464 50 mg + One capsule of placebo) once daily for 16 weeks
|
ABX464, 25mg
n=62 participants at risk
ABX464 25mg: ABX464 25mg (One capsule of ABX464 25 mg + One capsule of placebo) once daily for 16 weeks
|
Matching Placebo
n=64 participants at risk
Matching placebo will be adminstrated orally (Capsules) and daily for 16 weeks
Placebo: Two capsules of placebo once daily for 16 weeks
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
42.2%
27/64 • Number of events 29 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
30.2%
19/63 • Number of events 21 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
21.0%
13/62 • Number of events 14 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
7.8%
5/64 • Number of events 5 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Nervous system disorders
Burning sensation
|
3.1%
2/64 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Nervous system disorders
Restless legs syndrome
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
14.1%
9/64 • Number of events 9 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
6.3%
4/63 • Number of events 5 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
8.1%
5/62 • Number of events 5 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
6.2%
4/64 • Number of events 4 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
4/64 • Number of events 4 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
4.8%
3/63 • Number of events 4 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
4.8%
3/62 • Number of events 4 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
4.8%
3/63 • Number of events 3 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
5/64 • Number of events 5 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
3.2%
2/63 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.1%
2/64 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
3.2%
2/62 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Dispepsia
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
3.2%
2/62 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Frequent bowel mouvements
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Intestinal fistula
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Intestinal polip
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Melaena
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Odynophagia
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Prothrombin time prolonged
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
3.2%
2/63 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
3.1%
2/64 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
C-reactive protein increased
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
3.2%
2/63 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Lipase increased
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
3.2%
2/62 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Alanine aminotranferase increased
|
3.1%
2/64 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Glutamate Dehydrogenase increased
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
International normalised ratio indreased
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Neutrophil count increased
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
White cell count increased
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Blood cholesterol increased
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Blood fibrilogen decreased
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Blood fibrilogen increased
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Hematocrit decreased
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Human chorionic gonadotropin increased
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Liver function test increased
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Prostatic specific antigen increased
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Troponin I increased
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Troponin increased
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Troponin T increased
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
4.8%
3/63 • Number of events 3 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
3.1%
2/64 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Infections and infestations
Oral herpes
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Infections and infestations
Anal abcsess
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Infections and infestations
Cellulitis
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Infections and infestations
Dermatophytosis
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Infections and infestations
Herpes Virus infection
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Infections and infestations
Paronychia
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Infections and infestations
Pyoderma
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
5/64 • Number of events 6 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
4.7%
3/64 • Number of events 3 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.8%
5/64 • Number of events 5 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
2/64 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Coccydinia
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Ostheoporosis
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
3.2%
2/62 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyposphatemia
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
General disorders
Asthenia
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
3.2%
2/63 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
3.2%
2/62 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
General disorders
Fatigue
|
3.1%
2/64 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
General disorders
Pyrexia
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.1%
2/64 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.6%
1/64 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
3.2%
2/63 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pityriasis Rosea
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
3.1%
2/64 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Congestive cardiomyopathy
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Left ventricular hypertrophy
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Palpitations
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Tachycardia
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Psychiatric disorders
Affective disorder
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Psychiatric disorders
Depressed mood
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis migration
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Hepatobiliary disorders
Liver disorder
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
3.2%
2/62 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Reproductive system and breast disorders
Breast cyst
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Vascular disorders
Hot flush
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Endocrine disorders
Hypothiroidism
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Eye disorders
Eczema eyelids
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Immune system disorders
Mite allergy
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/62 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Surgical and medical procedures
Tooth extraction
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
1.6%
1/63 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
3.2%
2/62 • Number of events 2 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
1.6%
1/64 • Number of events 1 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/63 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/62 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
0.00%
0/64 • TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60