Trial Outcomes & Findings for Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis (NCT NCT03893565)
NCT ID: NCT03893565
Last Updated: 2022-04-27
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect or other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. AEs and SAEs were collected up to Week 14 (for participants who later entered the Double Blind ETP) and Week 12 (for participants who later entered OL Induction Phase).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
Up to a maximum of Week 14
Results posted on
2022-04-27
Participant Flow
This was a randomized, placebo-controlled study to evaluate the safety, tolerability, efficacy and dose-response of GSK2831781 in participants with ulcerative colitis. The study was conducted across 13 countries.
A total of 104 participants were enrolled in the study. This study was terminated based on the assessment of clinical data.
Participant milestones
| Measure |
Placebo IV
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 450 mg IV
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo SC
Participants from the placebo arm identified as responders based on Week 10 assessments during the Induction Phase received placebo subcutaneously (SC) every 4 weeks from Weeks 14 to 26 during the 20 week double-blind extended treatment phase (ETP). At Week 30, participants underwent an assessment following which they were followed up until Week 42.
|
GSK2831781 300 mg SC
Participants from the GSK2831781 arms identified as responders based on Week 10 assessments during the Induction Phase received GSK2831781 300 mg SC every 4 weeks from Weeks 14 to 26 during the 20-week double-blind ETP. At Week 30, participants underwent an assessment following which they were followed up until Week 42.
|
Open-label GSK2831781 450 mg IV
Participants identified as non-responders during the double-blind Induction phase at Week 10 were administered GSK2831781 450 mg IV on Weeks 12, 14, 18 and 22 during the open-label (OL) induction phase.
|
Open-label GSK2831781 300 mg SC
Participants from the Open-label induction phase who responded at Week 22 entered the 20-week (Week 22 to Week 42) open-label extended treatment phase and received GSK2831781 300 mg SC every 4 weeks from Week 26 until Week 38. Participants were followed up until Week 54.
|
|---|---|---|---|---|---|---|---|---|---|
|
Double-blind Induction Phase (10 Weeks)
STARTED
|
27
|
48
|
11
|
10
|
8
|
0
|
0
|
0
|
0
|
|
Double-blind Induction Phase (10 Weeks)
COMPLETED
|
21
|
32
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Double-blind Induction Phase (10 Weeks)
NOT COMPLETED
|
6
|
16
|
10
|
9
|
7
|
0
|
0
|
0
|
0
|
|
Double-blind Extended Treatment(20weeks)
STARTED
|
0
|
0
|
0
|
0
|
0
|
5
|
8
|
0
|
0
|
|
Double-blind Extended Treatment(20weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
4
|
0
|
0
|
|
Double-blind Extended Treatment(20weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
3
|
4
|
0
|
0
|
|
Open-label Induction Phase (10 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
42
|
0
|
|
Open-label Induction Phase (10 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
0
|
|
Open-label Induction Phase (10 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
30
|
0
|
|
Open-label Extended Treatment (20 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
|
Open-label Extended Treatment (20 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Open-label Extended Treatment (20 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
Reasons for withdrawal
| Measure |
Placebo IV
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 450 mg IV
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo SC
Participants from the placebo arm identified as responders based on Week 10 assessments during the Induction Phase received placebo subcutaneously (SC) every 4 weeks from Weeks 14 to 26 during the 20 week double-blind extended treatment phase (ETP). At Week 30, participants underwent an assessment following which they were followed up until Week 42.
|
GSK2831781 300 mg SC
Participants from the GSK2831781 arms identified as responders based on Week 10 assessments during the Induction Phase received GSK2831781 300 mg SC every 4 weeks from Weeks 14 to 26 during the 20-week double-blind ETP. At Week 30, participants underwent an assessment following which they were followed up until Week 42.
|
Open-label GSK2831781 450 mg IV
Participants identified as non-responders during the double-blind Induction phase at Week 10 were administered GSK2831781 450 mg IV on Weeks 12, 14, 18 and 22 during the open-label (OL) induction phase.
|
Open-label GSK2831781 300 mg SC
Participants from the Open-label induction phase who responded at Week 22 entered the 20-week (Week 22 to Week 42) open-label extended treatment phase and received GSK2831781 300 mg SC every 4 weeks from Week 26 until Week 38. Participants were followed up until Week 54.
|
|---|---|---|---|---|---|---|---|---|---|
|
Double-blind Induction Phase (10 Weeks)
Other
|
1
|
3
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Double-blind Induction Phase (10 Weeks)
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Induction Phase (10 Weeks)
Withdrawal by Subject
|
0
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Induction Phase (10 Weeks)
Lost to Follow-up
|
0
|
1
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Induction Phase (10 Weeks)
Study terminated by sponsor
|
5
|
5
|
9
|
0
|
6
|
0
|
0
|
0
|
0
|
|
Double-blind Induction Phase (10 Weeks)
Protocol-specified withdrawal criterion met
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Induction Phase (10 Weeks)
Lack of Efficacy
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Induction Phase (10 Weeks)
Adverse Event
|
0
|
2
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Extended Treatment(20weeks)
Other
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Double-blind Extended Treatment(20weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Double-blind Extended Treatment(20weeks)
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
0
|
0
|
|
Open-label Induction Phase (10 Weeks)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Open-label Induction Phase (10 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
|
Open-label Induction Phase (10 Weeks)
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
0
|
|
Open-label Induction Phase (10 Weeks)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
0
|
|
Open-label Extended Treatment (20 Weeks)
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
Baseline Characteristics
Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Placebo IV
n=27 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 450 mg IV
n=48 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=11 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=10 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=8 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
43.9 Years
STANDARD_DEVIATION 12.82 • n=5 Participants
|
40.7 Years
STANDARD_DEVIATION 12.70 • n=7 Participants
|
37.6 Years
STANDARD_DEVIATION 13.06 • n=5 Participants
|
42.5 Years
STANDARD_DEVIATION 15.06 • n=4 Participants
|
40.6 Years
STANDARD_DEVIATION 10.60 • n=21 Participants
|
41.4 Years
STANDARD_DEVIATION 12.75 • n=10 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
43 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
61 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian-Central/South Asian Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian-East Asian Heritage
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian-Japanese Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian-South East Asian Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White-Arabic/North African Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
|
25 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
95 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Mixed White race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to a maximum of Week 14Population: Safety Population comprised of all participants who received at least one dose of study treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect or other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. AEs and SAEs were collected up to Week 14 (for participants who later entered the Double Blind ETP) and Week 12 (for participants who later entered OL Induction Phase).
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=48 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=11 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=10 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=8 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=27 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Double-Blind Induction Phase
AEs
|
27 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
10 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Double-Blind Induction Phase
SAEs
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 10Population: Safety Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)
Vital signs were measured in a seated or semi-supine position after 5 minutes rest. The clinical concern range for vital signs were: systolic blood pressure (SBP) (lower: \<85 and upper: \> 160 millimeters of mercury \[mmHg\]); diastolic blood pressure (DBP) (lower: \<45 mmHg and upper: \>100 mmHg); pulse rate (PR) (lower: \<40 and upper: \>110 beats per minute \[bpm\]) and temperature (Temp) (lower: \<35 and upper: \>38 degree Celsius). Participants were counted in the worst-case category that their value changed to (low, within range or no change, or high), unless there was no change in their category. Participants whose value category was unchanged (e.g. High to High), or whose value became within range, were recorded in the "To within (w/in) Range or No Change category". Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100 percent (%).
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=48 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=11 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=10 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=8 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=27 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
DBP; To low; n=27, 47, 9, 8, 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
DBP; To w/in range or no change; n=27, 47, 9, 8, 7
|
47 Participants
|
9 Participants
|
8 Participants
|
7 Participants
|
27 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
DBP; To high; n=27, 47, 9, 8, 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
SBP; To low; n=27, 47, 10, 9, 6
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
SBP; To w/in range or no change; n=27, 47, 10, 9,6
|
45 Participants
|
9 Participants
|
9 Participants
|
6 Participants
|
26 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
SBP; To high; n=27, 47, 10, 9, 6
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
PR; To low; n=27, 47, 11, 9, 8
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
PR; To w/in range or no change; n=27, 47, 11, 9, 8
|
45 Participants
|
10 Participants
|
9 Participants
|
8 Participants
|
27 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
PR; To high; n=27, 47, 11, 9, 8
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Temp; To low; n=26, 46, 11, 10, 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Temp; To w/in range or no change; n=26,46,11,10,7
|
46 Participants
|
11 Participants
|
10 Participants
|
7 Participants
|
26 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Temp; To high; n=26, 46, 11, 10, 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 10Population: Safety Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (Hct) (low: 0.201 and high: \>0.599 proportion of red blood cells in blood); hemoglobin (Hgb) (low: \<80 and high: \>180 grams per liter \[g/L\]), lymphocytes (Lymph) (low: \<0.8x10\^9 cells/L); neutrophil (Neut) count (low: \<1.5x10\^9 cells/L); platelet (plat) count (low: \<100x10\^9 cells/L and high: \>550x10\^9 cells/L); leukocytes (leuko) (low: \<3x10\^9 cells/L and high: \>20x10\^9cells/L) and eosinophils (Eos) (high: \>=1x10\^9 cells/L). Participants were counted in the worst-case category that their value changed to (low, w/in range or no change, or high), unless there was no change in their category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=48 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=11 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=10 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=8 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=27 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Hgb; To high; n=24,45,5,7,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Leuko; To low; n=27,43,8,9,6
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Leuko; To w/in range or no change; n=27,43,8,9,6
|
41 Participants
|
8 Participants
|
8 Participants
|
6 Participants
|
27 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Leuko; To high; n=27,43,8,9,6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Lymph; To low; n=26,45,8,8,8
|
6 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Lymph; To w/in range or no change; n=26,45,8,8,8
|
39 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
25 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Neut; To low; n=26,42,7,9,8
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Neut; To w/in range or no change; n=26,42,7,9,8
|
40 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
26 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Plat; To low; n=26,43,9,8,6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Plat; To w/in range or no change; n=26,43,9,8,6
|
41 Participants
|
9 Participants
|
7 Participants
|
6 Participants
|
25 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Plat; To high; n=26,43,9,8,6
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Eos;w/in range or no change; n=25,45,9,8,7
|
44 Participants
|
9 Participants
|
8 Participants
|
7 Participants
|
24 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Eos; To high; n=25,45,9,8,7
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Hct; To low; n=24,43,7,6,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Hct; To w/in range or no change; n=24,43,7,6,7
|
43 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
24 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Hct; To high; n=24,43,7,6,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Hgb; To low; n=24,45,5,7,7
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Hgb; To w/in range or no change; n=24,45,5,7,7
|
45 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: Up to Week 10Population: Safety Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: albumin (Alb) (low: \<30 and high: \>55 g/L), calcium (Ca) (low: 2 and high: 2.75 millimoles per liter \[mmol/L\]), urea (high: \>10.5 mmol/L); creatinine (Creat) (high: change from Baseline \>26 micromoles per liter \[µmol/L\]), glucose (Glu) (low: \<3.5 and high: \>7.9 mmol/L); estimated glomerular filtration rate (eGFR) (low: \<60 milliliters per minute per 1.73 square meter \[mL/min/1.73m\^2)\]; potassium (Pot) (low: \<3 and high: \>5.5 mmol/L); sodium (Sod) (low: \<130 and high: \>150 mmol/L); protein (Pro) (low: \<50 and high: \>85 g/L) and C-reactive protein (CRP) (high: \>30 milligrams/L). Participants were counted in the worst-case category that their value changed to (low, w/in range or no change, or high), unless there was no change in their category.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=48 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=11 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=10 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=8 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=27 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Glu; To low; n=26,45,5,8,7
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Alb; To low; n=26,42,7,6,6
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Alb; To w/in range or no change; n=26,42,7,6,6
|
40 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
26 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Alb; To high; n=26,42,7,6,6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
CRP; To w/in range or no change; n=26, 46,9,10,8
|
36 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
25 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
CRP; To high; n=26, 46,9,10,8
|
10 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Cal; To low; n=26,45,7,4,7
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Cal; To w/in range or no change; n=26,45,7,4,7
|
45 Participants
|
7 Participants
|
3 Participants
|
7 Participants
|
25 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Cal; To high; n=26,45,7,4,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
eGFR; To low; n=24,46,6,9,7
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
eGFR; To w/in range or no change; n=24,46,6,9,7
|
45 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
23 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Glu; To w/in range or no change; n=26,45,5,8,7
|
43 Participants
|
5 Participants
|
8 Participants
|
7 Participants
|
25 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Glu; To high; n=26,45,5,8,7
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Pot; To low; n=27,44,10,7,8
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Pot; To w/in range or no change; n=27,44,10,7,8
|
43 Participants
|
10 Participants
|
7 Participants
|
8 Participants
|
27 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Pot; To high; n=27,44,10,7,8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Pro; To low; n=26,43,7,5,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Pro To w/in range or no change; n=26,43,7,5,7
|
41 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
26 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Pro; To high; n=26,43,7,5,7
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Sod; To low; n=25,45,10,8,8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Sod; To w/in range or no change; n=25,45,10,8,8
|
45 Participants
|
10 Participants
|
8 Participants
|
8 Participants
|
25 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Sod; To high; n=25,45,10,8,8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Urea; To w/in range or no change; n=26,45,5,6,7
|
45 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
26 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Urea; To high; n=26,45,5,6,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Creat; To w/in range or no change; n=27,44,9,6,7
|
44 Participants
|
9 Participants
|
6 Participants
|
7 Participants
|
27 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Creat; To high; n=27,44,9,6,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 10Population: Safety Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of liver function parameters. The clinical concern range for liver function parameters were: alanine aminotransferase (ALT) (high: \>=2 times upper limit of normal \[ULN\]); aspartate aminotransferase (AST) (high: \>=2 times ULN); alkaline phosphatase (ALP) (high: \>=2 times ULN) and bilirubin (Bil) (high: \>=1.5 times ULN). Participants were counted in the worst-case category that their value changed to (within range or no change, or high), unless there was no change in their category. Participants whose value category was unchanged (e.g. High to High), or whose value became within range, were recorded in the "To within (w/in) Range or No Change category".
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=48 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=11 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=10 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=8 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=27 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
ALT; To low; n=26,44,7,7,8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
ALT;To w/in range or no change; n=26,44,7,7,8
|
42 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
25 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
ALT; To high; n=26,44,7,7,8
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
AST; To low; n=26,45,7,8,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
AST; To w/in range or no change; n=26,45,7,8,7
|
44 Participants
|
7 Participants
|
8 Participants
|
7 Participants
|
26 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
AST; To high;n=26,45,7,8,7
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
ALP; To low; n=27,44,9,9,8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
ALP; To w/in range or no change; n=27,44,9,9,8
|
44 Participants
|
9 Participants
|
9 Participants
|
8 Participants
|
27 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
ALP; To high; n=27,44,9,9,8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Bil; To low; n=25,45,9,8,8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Bil; To w/in range or no change; n=25,45,9,8,8
|
45 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
25 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Bil; To high; n=25,45,9,8,8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 10Population: Safety Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)
Urine samples were collected for the assessment of urine parameters by dipstick and microscopy. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+ indicating proportional concentrations in the urine sample. The clinical concern range for urine parameters were: Bil (high: \>1+), glu (high: \>1+); ketone (ket) (high: \>2+); leuko (high: \>1+); leukocyte esterase (LE); nitrite (nit) (high: positive); occult blood (OB) (high: \>1+); potential of hydrogen (pH) (low: \<4.6 and high: \>8); prot (high:\>1+); erythrocytes (erythro) (high: \>3 cells per high power field \[hpf\]); specific gravity (sp gra) (low: \<1.001 and high: \>1.035) and urobilinogen (uro) (high: \>1 mg/deciliter).
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=48 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=11 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=10 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=8 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=27 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Bil; To w/in range or no change; n=27,47,10,9,8
|
46 Participants
|
10 Participants
|
9 Participants
|
8 Participants
|
27 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Bil; To high; n=27,47,10,9,8
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Glu; To w/in range or no change; n=27,47,10,10,8
|
47 Participants
|
10 Participants
|
10 Participants
|
8 Participants
|
27 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Glu; To high; n=27,47,10,10,8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Ket; To w/in range or no change; n=27,47,10,8,8
|
47 Participants
|
10 Participants
|
7 Participants
|
8 Participants
|
25 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Ket; To high; n=27,47,10,8,8
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
LE; To w/in range or no change; n=26,45,9,8,8
|
37 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
25 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
LE; To high; n=26,45,9,8,8
|
8 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Nit; To w/in range or no change; n=27,47,10,10,8
|
44 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
27 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Nit; To high; n=27,47,10,10,8
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
OB; To w/in range or no change; n=26,46,9,10,8
|
42 Participants
|
9 Participants
|
10 Participants
|
8 Participants
|
24 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
OB; To high; n=26,46,9,10,8
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
pH; To low; n=27,46,9,10,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
pH; To w/in range or no change; n=27,46,9,10,7
|
46 Participants
|
9 Participants
|
10 Participants
|
7 Participants
|
26 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
pH; To high; n=27,46,9,10,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Prot; To w/in range or no change; n=25,47,10,9,8
|
43 Participants
|
10 Participants
|
9 Participants
|
8 Participants
|
24 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Prot; To high; n=25,47,10,9,8
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Uro; To w/in range or no change; n=27,47,10,8,8
|
47 Participants
|
10 Participants
|
8 Participants
|
8 Participants
|
27 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Uro; To high; n=27,47,10,8,8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Leuko; To w/in range or no change; n=9,18,2,3,1
|
15 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
8 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Leuko; To high; n=9,18,2,3,1
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Erythro; To w/in range or no change; n=9,18,2,3,1
|
16 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
9 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Erythro; To high; n=9,18,2,3,1
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Sp gra; To low; n=25,47,5,7,8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Sp gra; To w/in range or no change; n=25,47,5,7,8
|
44 Participants
|
5 Participants
|
7 Participants
|
8 Participants
|
21 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
Sp gra; To high; n=25,47,5,7,8
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to Week 10Population: Safety Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)
Twelve lead electrocardiograms (ECGs) were obtained using an ECG machine that automatically calculated the QT interval corrected for heart rate according to either Bazett's formula (QTcB) or Fridericia's formula (QTcF). The clinical concern range for the QTcB and QTcF intervals was upper: \>450 milliseconds.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=48 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=11 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=10 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=8 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=27 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase
QTcB; No change or decrease to <450; n=26,44,8,9,7
|
41 Participants
|
6 Participants
|
7 Participants
|
7 Participants
|
22 Participants
|
|
Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase
QTcB; Any increase to >=450; n=26,44,8,9,7
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase
QTcF; No change or decrease to <450; n=26,46,7,9,7
|
45 Participants
|
7 Participants
|
8 Participants
|
7 Participants
|
26 Participants
|
|
Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase
QTcF; Any increase to >=450; n=26,46,7,9,7
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 10Population: Intent-To-Treat-Exposed (ITTE) Population comprised of all enrolled participants who received at least one dose of study treatment, and who had at least one valid post dose assessment. Only those participants with data available at the specified time points were analyzed.
The Complete 4-domain Mayo Score is a 12-point scoring system where disease is evaluated based on the four components: stool frequency, rectal bleeding, physician global assessment (PGA) and endoscopic appearance (with mild friability associated with an endoscopic score of 1). The score for each component ranges from 0 (normal/none) to 3 (severe). The complete Mayo score is calculated as the sum of four components and ranges from 0 to 12. Higher scores indicate greater disease severity. Baseline value was the latest pre-dose assessment with a non-missing value from Double-Blind Induction study phase. Change from Baseline was calculated as value at specified time point minus Baseline value.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=36 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=4 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=2 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=3 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=21 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Change From Baseline in Complete 4-domain Mayo Score at Week 10
|
-1.4 Scores on a scale
Standard Error 0.36
|
-0.3 Scores on a scale
Standard Error 0.48
|
-1.0 Scores on a scale
Standard Error 2.00
|
-2.3 Scores on a scale
Standard Error 0.33
|
-1.5 Scores on a scale
Standard Error 0.45
|
SECONDARY outcome
Timeframe: Week 14 to 30Population: Safety Extended Treatment Population comprised of all participants who received at least one dose of study treatment in the Extended Treatment Phase
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect or other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=8 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=5 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With AEs and SAEs-Double-Blind Extended Treatment Phase
AEs
|
3 Participants
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With AEs and SAEs-Double-Blind Extended Treatment Phase
SAEs
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 14 to 30Population: Safety Extended Treatment Population
Vital signs were measured in a seated or semi-supine position after 5 minutes rest. The clinical concern range for vital signs were: SBP (lower: \<85 and upper: \> 160 mmHg); DBP (lower: \<45 mmHg and upper: \>100 mmHg); PR (lower: \<40 and upper: \>110 bpm) and Temp (lower: \<35 and upper: \>38 degree Celsius). Participants were counted in the worst-case category that their value changed to (low, within range or no change, or high), unless there was no change in their category. Participants whose value category was unchanged (e.g. High to High), or whose value became within range, were recorded in the "To w/in Range or No Change category". Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=8 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=5 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
DBP; To low
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
DBP; To w/in range or no change
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
DBP; To high
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
SBP; To low
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
SBP; To w/in range or no change
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
SBP; To high
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
PR; To low
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
PR; To w/in range or no change
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
PR; To high
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Temp; To low
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Temp; To w/in range or no change
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Temp; To high
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 14 to 30Population: Safety Extended Treatment Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: Hct (low: 0.201 and high: \>0.599 proportion of red blood cells in blood); Hgb (low: \<80 and high: \>180 g/L), Lymph (low: \<0.8x10\^9 cells/L); Neut count (low: \<1.5x10\^9 cells/L); plat count (low: \<100x10\^9 cells/L and high: \>550x10\^9 cells/L); leuko (low: \<3x10\^9 cells/L and high: \>20x10\^9cells/L) and Eos (high: \>=1x10\^9 cells/L). Participants were counted in the worst-case category that their value changed to (low, within range or no change, or high), unless there was no change in their category. Participants whose value category was unchanged (e.g. High to High), or whose value became within range, were recorded in the "To w/in Range or No Change category". Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=8 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=5 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Eos;To w/in range or no change; n=4,8
|
8 Participants
|
—
|
—
|
—
|
4 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Eos; To high; n=4,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Hct; To low; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Hct; To w/in range or no change; n=5,8
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Hct; To high; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Hgb; To low; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Hgb; To w/in range or no change; n=5,8
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Hgb; To high; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Leuko; To low; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Leuko; To w/in range or no change; n=5,8
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Leuko; To high; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Lymph; To low; n=5,8
|
2 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Lymph; To w/in range or no change; n=5,8
|
6 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Neut; To low; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Neut; To w/in range or no change; n=5,8
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Plat; To low; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Plat; To w/in range or no change; n=5,8
|
6 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Plat; To high; n=5,8
|
2 Participants
|
—
|
—
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 14 to 30Population: Safety Extended Treatment Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: Alb (low: \<30 and high: \>55 g/L), C) (low: 2 and high: 2.75 mmol/L), urea (high: \>10.5 mmol/L); Creat (high: change from Baseline \>26 µmol/L), Glu (low: \<3.5 and high: \>7.9 mmol/L); eGFR (low: \<60 mL/min/1.73m\^2\]; Pot low: \<3 and high: \>5.5 mmol/L); Sod (low: \<130 and high: \>150 mmol/L); Pro (low: \<50 and high: \>85 g/L) and CRP (high: \>30 milligrams/L). Participants were counted in the worst-case category that their value changed to (low, within range or no change, or high), unless there was no change in their category. Participants whose value category was unchanged (e.g. High to High), or whose value became within range, were recorded in the "To w/in Range or No Change category". Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=8 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=5 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Pot; To low;n=4,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Alb; To low; n=5,8
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Alb; To w/in range or no change; n=5,8
|
7 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Alb; To high; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
CRP; To w/in range or no change; n=5,8
|
6 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
CRP; To high; n=5,8
|
2 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Cal; To low; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Cal; To w/in range or no change; n=5,8
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Cal; To high; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
eGFR; To low; n=4,8
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
eGFR; To w/in range or no change; n=4,8
|
7 Participants
|
—
|
—
|
—
|
4 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Glu; To low; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Glu; To w/in range or no change; n=5,8
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Glu; To high; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Pot; To w/in range or no change; n=4,8
|
8 Participants
|
—
|
—
|
—
|
4 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Pot; To high; n=4,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Pro; To low; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Pro To w/in range or no change; n=5,8
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Pro; To high; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Sod; To low; n=4,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Sod; To w/in range or no change; n=4,8
|
8 Participants
|
—
|
—
|
—
|
4 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Sod; To high; n=4,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Urea; To w/in range or no change; n=5,8
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Urea; To high; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Creat; To w/in range or no change; n=5,8
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Creat; To high; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 14 to 30Population: Safety Extended Treatment Population
Blood samples were collected for the assessment of liver function parameters. The clinical concern range for liver function parameters were: ALT (high: \>=2 times ULN); AST (high: \>=2 times ULN); ALP (high: \>=2 times ULN) and Bil (high: \>=1.5 times ULN). Participants were counted in the worst-case category that their value changed to (low, within range or no change, or high), unless there was no change in their category. Participants whose value category was unchanged (e.g. High to High), or whose value became within range, were recorded in the "To w/in Range or No Change category".
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=8 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=5 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
ALT; To low
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
ALT;To w/in range or no change
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
ALT; To high
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
AST; To low
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
AST; To w/in range or no change
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
AST; To high
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
ALP; To low
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
ALP; To w/in range or no change
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
ALP; To high
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Bil; To low
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Bil; To w/in range or no change
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Bil; To high
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 14 to 30Population: Safety Extended Treatment Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)
Urine samples were collected for the assessment of urine parameters by dipstick and microscopy. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+ indicating proportional concentrations in the urine sample. The clinical concern range for urine parameters were: Bil (high: \>1+), glu (high: \>1+); ket (high: \>2+); leuko (high: \>1+); LE; nit (high: positive); OB (high: \>1+); pH (low: \<4.6 and high: \>8); prot (high:\>1+); erythro (high: \>3 cells per hpf); sp gra (low: \<1.001 and high: \>1.035) and uro (high: \>1 mg/deciliter).
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=8 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=5 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Bil; To w/in range or no change; n=5,8
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Bil; To high; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Glu; To w/in range or no change; n=5,8
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Glu; To high; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Ket; To w/in range or no change; n=5,8
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Ket; To high; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
LE; To w/in range or no change; n=5,8
|
8 Participants
|
—
|
—
|
—
|
3 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
LE; To high; n=5,8
|
0 Participants
|
—
|
—
|
—
|
2 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Nit; To w/in range or no change; n=5,8
|
7 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Nit; To high; n=5,8
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
OB; To w/in range or no change; n=5,8
|
7 Participants
|
—
|
—
|
—
|
4 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
OB; To high; n=5,8
|
1 Participants
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
pH; To low; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
pH; To w/in range or no change; n=5,8
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
pH; To high; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Prot; To w/in range or no change; n=5,8
|
8 Participants
|
—
|
—
|
—
|
4 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Prot; To high; n=5,8
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Uro; To w/in range or no change; n=5,8
|
8 Participants
|
—
|
—
|
—
|
5 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Uro; To high; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Leuko; To w/in range or no change; n=1,2
|
1 Participants
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Leuko; To high; n=1,2
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Erythro; To w/in range or no change; n=1,2
|
2 Participants
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Erythro; To high; n=1,2
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Sp gra; To low; n=5,8
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Sp gra; To w/in range or no change; n=5,8
|
6 Participants
|
—
|
—
|
—
|
4 Participants
|
|
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
Sp gra; To high; n=5,8
|
2 Participants
|
—
|
—
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 14 to 30Population: Safety Extended Treatment Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the QTcB and QTcF intervals. The clinical concern range for the QTcB and QTcF intervals was upper: \>450 milliseconds.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=8 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=4 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With Maximum QTc Values Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
QTcB; No change or decrease to <450; n=4,6
|
6 Participants
|
—
|
—
|
—
|
4 Participants
|
|
Number of Participants With Maximum QTc Values Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
QTcB; Any increase to >=450; n=4,6
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Maximum QTc Values Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
QTcF; No change or decrease to <450; n=3,6
|
6 Participants
|
—
|
—
|
—
|
3 Participants
|
|
Number of Participants With Maximum QTc Values Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase
QTcF; Any increase to >=450; n=3,6
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 10Population: ITTE Population. Only those participants with data available at the specified time points were analyzed.
The adapted Mayo clinical score consists of three components: stool frequency, rectal bleeding, and endoscopic appearance. The score for each component ranges from 0 (normal/none) to 3 (severe). The adapted Mayo endoscopic score of 0 indicates normal or inactive disease and 1 indicates mild disease (erythema, decreased vascular pattern).
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=36 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=4 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=2 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=3 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=21 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With Adapted Mayo Endoscopic Score of 0 or 1 at Week 10-Double-Blind Induction Phase
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 10Population: ITTE Population. Only those participants with data available at the specified time points were analyzed.
The adapted Mayo clinical score is based on the complete 4-domain Mayo clinical score, but without the PGA. It consists of three components: stool frequency, rectal bleeding, and mucosal endoscopic appearance. The score for each component ranges from 0 (normal/none) to 3 (severe). The total adapted Mayo score is calculated as the sum of all three components and ranges from 0 to 9. Higher scores indicate greater disease severity. Clinical remission is defined as adapted Mayo Clinical Score of \<=2 with no individual sub-score \>1 and a rectal bleeding sub score of 0 with stool frequency sub score not greater than Baseline.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=36 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=4 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=2 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=3 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=21 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With Adapted Mayo Clinical Remission at Week 10-Double-Blind Induction Phase
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 10Population: ITTE Population. Only those participants with data available at the specified time points were analyzed.
The adapted Mayo clinical score is based on the complete 4-domain Mayo clinical score, but without the PGA. It consists of three components: stool frequency, rectal bleeding, and mucosal endoscopic appearance. The score for each component ranges from 0 (normal/none) to 3 (severe). The total adapted Mayo score is calculated as the sum of all three components and ranges from 0 to 9. Higher scores indicate greater disease severity. Clinical response is defined as reduction in adapted Mayo clinical score \>=3 points from Baseline and \>=30% from Baseline and decrease in the rectal bleeding sub-score of \>=1 point from Baseline (or a score of 0 or 1).
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=36 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=4 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=2 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=3 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=21 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With Adapted Mayo Clinical Response at Week 10-Double-Blind Induction Phase
|
6 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 10Population: ITTE Population. Only those participants with data available at the specified time points were analyzed.
The Complete 4-domain Mayo Score is a 12-point scoring system where disease is evaluated based on the four components: stool frequency, rectal bleeding, PGA and endoscopic appearance (with mild friability associated with an endoscopic score of 1). Symptomatic remission is defined as a rectal bleeding subscore of 0, and a stool frequency subscore of \<=1, with no worsening from Baseline.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=36 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=4 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=2 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=3 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=21 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With Symptomatic Remission at Week 10-Double-Blind Induction Phase
|
5 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 6, and 10Population: ITTE Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
The partial Mayo clinical score is based on the complete 4-domain Mayo clinical score but without the endoscopy sub-score. It consists of three components: stool frequency, rectal bleeding, and PGA. The score for each component ranges from 0 (normal/none) to 3 (severe). The total partial Mayo score is calculated as the sum of all three components and ranges from 0 to 9. Higher scores indicate greater disease severity. Baseline value was the latest pre-dose assessment with a non-missing value from Double-Blind Induction study phase. Change from Baseline was calculated as value at specified time point minus Baseline value.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=48 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=11 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=10 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=8 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=27 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase
Week 2; n=27, 47, 11, 10, 8
|
-0.6 Scores on a scale
Standard Error 0.22
|
-1.0 Scores on a scale
Standard Error 0.50
|
0.5 Scores on a scale
Standard Error 0.54
|
-1.3 Scores on a scale
Standard Error 0.65
|
-0.8 Scores on a scale
Standard Error 0.33
|
|
Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase
Week 4; n=26, 46, 8, 8, 7
|
-0.7 Scores on a scale
Standard Error 0.28
|
-1.4 Scores on a scale
Standard Error 0.60
|
-0.4 Scores on a scale
Standard Error 0.18
|
-1.7 Scores on a scale
Standard Error 0.52
|
-1.0 Scores on a scale
Standard Error 0.31
|
|
Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase
Week 6; n=24, 44, 8, 6, 8
|
-0.8 Scores on a scale
Standard Error 0.31
|
-1.0 Scores on a scale
Standard Error 0.53
|
-0.8 Scores on a scale
Standard Error 0.31
|
-2.6 Scores on a scale
Standard Error 0.53
|
-1.3 Scores on a scale
Standard Error 0.40
|
|
Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase
Week 10; n=22, 39, 4, 4, 4
|
-1.0 Scores on a scale
Standard Error 0.32
|
0.3 Scores on a scale
Standard Error 0.48
|
-1.0 Scores on a scale
Standard Error 0.41
|
-2.0 Scores on a scale
Standard Error 0.41
|
-1.1 Scores on a scale
Standard Error 0.44
|
SECONDARY outcome
Timeframe: Baseline and Week 10Population: ITTE Population. Only those participants with data available at the specified time points were analyzed
The adapted Mayo clinical score is based on the complete 4-domain Mayo clinical score, but without the PGA. It consists of three components: stool frequency, rectal bleeding, and mucosal endoscopic appearance. The total adapted Mayo endoscopy score ranges from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]). Baseline value was the latest pre-dose assessment with a non-missing value from Double-Blind Induction study phase. Change from Baseline was calculated as value at specified time point minus Baseline value.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=36 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=4 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=2 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=3 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=21 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Change From Baseline in Adapted Mayo Endoscopy Score at Week 10-Double-Blind Induction Phase
|
-0.1 Scores on a scale
Standard Error 0.12
|
0.0 Scores on a scale
Standard Error 0.00
|
0.5 Scores on a scale
Standard Error 0.50
|
-0.3 Scores on a scale
Standard Error 0.33
|
-0.2 Scores on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline and Week 10Population: ITTE Population. Only those participants with data available at the specified time points were analyzed
UCEIS was used as an additional tool to assess disease activity based on 3 sub-scales: endoscopic vascular pattern, bleeding, erosions and ulcerations. Individual sub-scale scores were vascular pattern (0=Normal, 1=Patchy loss, 2=Obliterated); bleeding (0=None, 1=Mucosal, 2=Luminal mild, 3=Luminal severe); erosions and ulcerations (0=None, 1=Erosions, 2=Superficial ulcer, 3=Deep ulcer). UCEIS total score was calculated as the sum of all 3 sub-scale scores and ranges from 0 to 8, with higher scores indicating more severe disease. Baseline value was the latest pre-dose assessment with a non-missing value from Double-Blind Induction study phase. Change from Baseline was calculated as value at specified time point minus Baseline value.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=36 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=4 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=2 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=3 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=21 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) at Week 10-Double-Blind Induction Phase
|
-0.0 Scores on a scale
Standard Error 0.25
|
0.5 Scores on a scale
Standard Error 0.65
|
1.0 Scores on a scale
Standard Error 0.00
|
0.0 Scores on a scale
Standard Error 0.58
|
-0.1 Scores on a scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Week 10Population: ITTE Population. Only those participants with data available at the specified time points were analyzed.
RHI was assessed by central reading of gut pinch biopsies. The RHI Score is a continuous score, ranging from 0-33 with higher scores indicating more severe disease. RHI Remission is defined as an RHI score \<=6. Responders were defined as number of participants with RHI score \<=6.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=36 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=4 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=2 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=3 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=21 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Responders for Robarts Histopathology Index (RHI) Remission at Week 10-Double-Blind Induction Phase
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 10Population: ITTE Population. Only those participants with data available at the specified time points were analyzed.
Nancy Histological Index was assessed by central reading of gut pinch biopsies. Key domains for scoring of the indices include chronic inflammatory infiltrate, neutrophils in the epithelium, lamina propria neutrophils, erosion and ulceration scored from 0 to 3 and multiplied by a weighting factor. The total Nancy Histological Index score is calculated by summing the weighted scores of the histological items, with total scores ranging from 0 (no disease activity) to 33 (severe disease activity). Nancy Index Remission was defined as a grade of 0 or 1. Responders were defined as number of participants with Nancy Index score of 0 or 1.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=36 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=4 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=2 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=3 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=21 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Responders for Nancy Histological Index Remission at Week 10-Double-Blind Induction Phase
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 10Population: ITTE Population. Only those participants with data available at the specified time points were analyzed.
The Geboes Index is divided in 6 grades: architectural changes \[grade 0\], chronic inflammatory infiltrate \[grade 1\], lamina propria neutrophils and eosinophils \[grade 2\], neutrophils in epithelium \[grade 3\], crypt destruction \[grade 4\] and erosions or ulcerations \[grade 5\]. The subscores for grade 0 to 4 ranges from 0 (none/no abnormality) to 3 (marked increase/severe abnormality) and for grade 5 ranges from 0 (No erosion, ulceration, or granulation tissue) to 4 (Ulcer or granulation tissue). The overall Geboes score is derived by summing the subscores of the grades and ranges from 0 to 22, with higher scores indicating greater disease severity. Geboes Histological Remission was defined as a Geboes score \<2. Responders were defined as number of participants with Geboes score \<2.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=36 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=4 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=2 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=3 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=21 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Responders for Geboes Histological Index Remission at Week 10-Double-Blind Induction Phase
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 6, and 10Population: ITTE Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Serum samples were collected at indicated time points to measure CRP levels. Baseline value was the latest pre-dose assessment with a non-missing value from Double-Blind Induction study phase. Change from Baseline was calculated as value at specified time point minus Baseline value.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=48 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=11 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=10 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=8 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=27 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase
Week 2; n=27, 47, 11, 10, 8
|
1.01 Milligrams per liter
Standard Deviation 8.004
|
8.23 Milligrams per liter
Standard Deviation 16.881
|
25.14 Milligrams per liter
Standard Deviation 62.574
|
-7.71 Milligrams per liter
Standard Deviation 14.627
|
-1.52 Milligrams per liter
Standard Deviation 8.508
|
|
Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase
Week 4; n=26,45,7,7,7
|
6.73 Milligrams per liter
Standard Deviation 21.625
|
0.74 Milligrams per liter
Standard Deviation 3.376
|
26.23 Milligrams per liter
Standard Deviation 62.003
|
-9.41 Milligrams per liter
Standard Deviation 18.059
|
-3.38 Milligrams per liter
Standard Deviation 8.188
|
|
Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase
Week 6; n=24,45,8,6,8
|
4.45 Milligrams per liter
Standard Deviation 13.491
|
2.34 Milligrams per liter
Standard Deviation 7.016
|
12.20 Milligrams per liter
Standard Deviation 15.566
|
-8.16 Milligrams per liter
Standard Deviation 18.602
|
-3.09 Milligrams per liter
Standard Deviation 6.748
|
|
Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase
Week 10; n=22,39,4,4,4
|
8.99 Milligrams per liter
Standard Deviation 21.549
|
8.40 Milligrams per liter
Standard Deviation 8.102
|
6.75 Milligrams per liter
Standard Deviation 13.749
|
-8.48 Milligrams per liter
Standard Deviation 20.407
|
2.89 Milligrams per liter
Standard Deviation 9.460
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 6, and 10Population: ITTE Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Fecal samples were collected at indicated time points to measure fecal calprotectin. Baseline value was the latest pre-dose assessment with a non-missing value from Double-Blind Induction study phase. Ratio to Baseline is the value at specified time point divided by Baseline value
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=48 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=11 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=10 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=8 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=27 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase
Week 2; n=25,40,9,9,6
|
0.90 Ratio
Geometric Coefficient of Variation 504.70
|
0.57 Ratio
Geometric Coefficient of Variation 206.90
|
2.05 Ratio
Geometric Coefficient of Variation 565.80
|
0.57 Ratio
Geometric Coefficient of Variation 200.43
|
1.28 Ratio
Geometric Coefficient of Variation 311.68
|
|
Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase
Week 4; n=3,2,0,2,0
|
1.58 Ratio
Geometric Coefficient of Variation 794.82
|
—
|
1.60 Ratio
Geometric Coefficient of Variation 55.72
|
—
|
0.28 Ratio
Geometric Coefficient of Variation 296.27
|
|
Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase
Week 6; n=23,37,7,6,7
|
0.99 Ratio
Geometric Coefficient of Variation 576.84
|
4.01 Ratio
Geometric Coefficient of Variation 8478.60
|
3.42 Ratio
Geometric Coefficient of Variation 477.17
|
2.51 Ratio
Geometric Coefficient of Variation 182.31
|
0.99 Ratio
Geometric Coefficient of Variation 688.97
|
|
Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase
Week 10; n=20,31,3,3,4
|
1.27 Ratio
Geometric Coefficient of Variation 961.25
|
3.82 Ratio
Geometric Coefficient of Variation 76.67
|
8.50 Ratio
Geometric Coefficient of Variation 2110.12
|
0.50 Ratio
Geometric Coefficient of Variation 251.03
|
1.68 Ratio
Geometric Coefficient of Variation 217.05
|
SECONDARY outcome
Timeframe: Week 14 (pre-dose, 24, 72 and 168 hours post-dose); Week 18 (pre-dose and early withdrawal post-dose)Population: Pharmacokinetic Double-Blind Extended Population comprised of all participants in the Safety Extended Treatment Phase population who had at least 1 non-missing PK assessment in the Extended Treatment phase. Only those participants with data at more than two of the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK2831781. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK2831781 450 mg IV
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=3 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve Over the 1st Dosing Interval (AUC[0-tau]) for GSK2831781 Following SC Dosing in Double-Blind Extended Treatment Phase
|
—
|
—
|
—
|
—
|
24336.92 Hours*micrograms per milliliter
Geometric Coefficient of Variation 23.797
|
SECONDARY outcome
Timeframe: Week 14 (pre-dose, 24, 72 and 168 hours post-dose); Week 18 (pre-dose and early withdrawal post-dose)Population: Pharmacokinetic Double-Blind Extended Population. Only those participants with data at more than two of the specified time points were analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK2831781. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK2831781 450 mg IV
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=3 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of GSK2831781 Observed Following 1st SC Dosing in Double-Blind Extended Treatment Phase
|
—
|
—
|
—
|
—
|
55.64 Micrograms per milliliter
Geometric Coefficient of Variation 13.374
|
SECONDARY outcome
Timeframe: Week 14 (pre-dose, 24, 72 and 168 hours post-dose); Week 18 (pre-dose and early withdrawal post-dose)Population: Pharmacokinetic Double-Blind Extended Population. Only those participants with data at more than two of the specified time points were analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK2831781. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK2831781 450 mg IV
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=3 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Time at Which the Maximum Concentration is Observed (Tmax) for GSK2831781 Following 1st SC Dosing in Double-Blind Extended Treatment Phase
|
—
|
—
|
—
|
—
|
72.03 Hours
Interval 24.3 to 170.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, and 10Population: Safety Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)
Serum samples were assessed for the presence of anti-drug antibodies using a tiered approach. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'confirmed positive'.
Outcome measures
| Measure |
GSK2831781 450 mg IV
n=48 Participants
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=11 Participants
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=10 Participants
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=8 Participants
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo IV
n=27 Participants
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase
Baseline; n=27,48,11,10,8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase
Week 2; n=27,47,11,10,8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase
Week 4; n=25,46,7,7,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase
Week 6; n=1,3,3,0,3
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase
Week 10; n=22,39,4,4,4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo IV
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
GSK2831781 450 mg IV
Serious events: 6 serious events
Other events: 26 other events
Deaths: 0 deaths
GSK2831781 300 mg IV
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
GSK2831781 150 mg IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
GSK2831781 45 mg IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo SC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
GSK2831781 300 mg SC
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Open-label GSK2831781 450 mg IV
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Open-label GSK2831781 300 mg SC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo IV
n=27 participants at risk
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 450 mg IV
n=48 participants at risk
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=11 participants at risk
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=10 participants at risk
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=8 participants at risk
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo SC
n=5 participants at risk
Participants from the placebo arm identified as responders based on Week 10 assessments during the Induction Phase received placebo subcutaneously (SC) every 4 weeks from Weeks 14 to 26 during the 20 week double-blind extended treatment phase (ETP). At Week 30, participants underwent an assessment following which they were followed up until Week 42.
|
GSK2831781 300 mg SC
n=8 participants at risk
Participants from the GSK2831781 arms identified as responders based on Week 10 assessments during the Induction Phase received GSK2831781 300 mg SC every 4 weeks from Weeks 14 to 26 during the 20-week double-blind ETP. At Week 30, participants underwent an assessment following which they were followed up until Week 42.
|
Open-label GSK2831781 450 mg IV
n=42 participants at risk
Participants identified as non-responders during the double-blind Induction phase at Week 10 were administered GSK2831781 450 mg IV on Weeks 12, 14, 18 and 22 during the open-label (OL) induction phase.
|
Open-label GSK2831781 300 mg SC
n=7 participants at risk
Participants from the Open-label induction phase who responded at Week 22 entered the 20-week (Week 22 to Week 42) open-label extended treatment phase and received GSK2831781 300 mg SC every 4 weeks from Week 26 until Week 38. Participants were followed up until Week 54.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
6.2%
3/48 • Number of events 3 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
8.3%
4/48 • Number of events 4 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
9.1%
1/11 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
12.5%
1/8 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
4.8%
2/42 • Number of events 2 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
Other adverse events
| Measure |
Placebo IV
n=27 participants at risk
Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 450 mg IV
n=48 participants at risk
Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 300 mg IV
n=11 participants at risk
Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 150 mg IV
n=10 participants at risk
Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
GSK2831781 45 mg IV
n=8 participants at risk
Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.
|
Placebo SC
n=5 participants at risk
Participants from the placebo arm identified as responders based on Week 10 assessments during the Induction Phase received placebo subcutaneously (SC) every 4 weeks from Weeks 14 to 26 during the 20 week double-blind extended treatment phase (ETP). At Week 30, participants underwent an assessment following which they were followed up until Week 42.
|
GSK2831781 300 mg SC
n=8 participants at risk
Participants from the GSK2831781 arms identified as responders based on Week 10 assessments during the Induction Phase received GSK2831781 300 mg SC every 4 weeks from Weeks 14 to 26 during the 20-week double-blind ETP. At Week 30, participants underwent an assessment following which they were followed up until Week 42.
|
Open-label GSK2831781 450 mg IV
n=42 participants at risk
Participants identified as non-responders during the double-blind Induction phase at Week 10 were administered GSK2831781 450 mg IV on Weeks 12, 14, 18 and 22 during the open-label (OL) induction phase.
|
Open-label GSK2831781 300 mg SC
n=7 participants at risk
Participants from the Open-label induction phase who responded at Week 22 entered the 20-week (Week 22 to Week 42) open-label extended treatment phase and received GSK2831781 300 mg SC every 4 weeks from Week 26 until Week 38. Participants were followed up until Week 54.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
9.1%
1/11 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
9.5%
4/42 • Number of events 4 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
9.1%
1/11 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
9.1%
1/11 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Ear and labyrinth disorders
Vertigo
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
9.1%
1/11 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
9.1%
1/11 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
25.0%
12/48 • Number of events 13 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
18.2%
2/11 • Number of events 2 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
20.0%
2/10 • Number of events 2 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
14.3%
1/7 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
9.1%
1/11 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
General disorders
Pain
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
9.1%
1/11 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Infections and infestations
COVID-19
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
6.2%
3/48 • Number of events 3 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
9.1%
1/11 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
4.2%
2/48 • Number of events 2 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
9.1%
1/11 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
10.0%
1/10 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
12.5%
1/8 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
9.1%
1/11 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
9.1%
1/11 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
9.1%
1/11 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
4.2%
2/48 • Number of events 2 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
12.5%
1/8 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Nervous system disorders
Headache
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
8.3%
4/48 • Number of events 6 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
4.8%
2/42 • Number of events 2 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
9.1%
1/11 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Psychiatric disorders
Somatic symptom disorder
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
9.1%
1/11 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
9.1%
1/11 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
12.5%
1/8 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
6.2%
3/48 • Number of events 3 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
9.1%
1/11 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Vascular disorders
Hypertension
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
12.5%
1/8 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
12.5%
1/8 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
12.5%
1/8 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Cardiac disorders
Myocardial fibrosis
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
12.5%
1/8 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
12.5%
1/8 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
12.5%
1/8 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
12.5%
1/8 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
12.5%
1/8 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Investigations
Heart rate decreased
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
20.0%
1/5 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
4.2%
2/48 • Number of events 2 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
4.2%
2/48 • Number of events 2 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 2 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Infections and infestations
Suspected COVID-19
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
4.8%
2/42 • Number of events 2 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
4.2%
2/48 • Number of events 2 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Investigations
Body temperature increased
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Investigations
Platelet count decreased
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Investigations
Weight decreased
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
4.8%
2/42 • Number of events 2 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.4%
1/42 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
14.3%
1/7 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Cardiac disorders
Arrhythmia
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Eye disorders
Blepharitis
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Eye disorders
Vitreous floaters
|
3.7%
1/27 • Number of events 2 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
4.2%
2/48 • Number of events 2 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Gastrointestinal disorders
Toothache
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
General disorders
Asthenia
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
General disorders
Fatigue
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
General disorders
Peripheral swelling
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
General disorders
Pyrexia
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Infections and infestations
Gingivitis
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Infections and infestations
Nasal herpes
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Investigations
Blood glucose increased
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Investigations
Glucose urine present
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Nervous system disorders
Migraine
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.7%
1/27 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Vascular disorders
Haematoma
|
3.7%
1/27 • Number of events 2 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/48 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
|
Vascular disorders
Thrombosed varicose vein
|
0.00%
0/27 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
2.1%
1/48 • Number of events 1 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/11 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/10 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/5 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/8 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/42 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
0.00%
0/7 • Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP
Non-SAEs and SAEs were collected in Safety Population for Double-blind induction phase, Safety ETP for double-blind ETP, Safety OL induction and Safety OL ETP for OL induction phase and OL ETP respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER