Trial Outcomes & Findings for Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension (NCT NCT00783094)
NCT ID: NCT00783094
Last Updated: 2011-03-29
Results Overview
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
422 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2011-03-29
Participant Flow
Participant milestones
| Measure |
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Randomized Double-Blind Treatment Period
STARTED
|
142
|
140
|
140
|
|
Randomized Double-Blind Treatment Period
COMPLETED
|
135
|
128
|
131
|
|
Randomized Double-Blind Treatment Period
NOT COMPLETED
|
7
|
12
|
9
|
|
Open-Label Extension Period
STARTED
|
135
|
128
|
131
|
|
Open-Label Extension Period
COMPLETED
|
113
|
109
|
101
|
|
Open-Label Extension Period
NOT COMPLETED
|
22
|
19
|
30
|
Reasons for withdrawal
| Measure |
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Randomized Double-Blind Treatment Period
Adverse Event
|
4
|
5
|
5
|
|
Randomized Double-Blind Treatment Period
Lack of Efficacy
|
0
|
2
|
1
|
|
Randomized Double-Blind Treatment Period
Physician Decision
|
0
|
2
|
0
|
|
Randomized Double-Blind Treatment Period
Protocol Violation
|
1
|
2
|
1
|
|
Randomized Double-Blind Treatment Period
Withdrawal by Subject
|
2
|
1
|
2
|
|
Open-Label Extension Period
Adverse Event
|
12
|
7
|
16
|
|
Open-Label Extension Period
Death
|
0
|
0
|
1
|
|
Open-Label Extension Period
Protocol Violation
|
4
|
5
|
7
|
|
Open-Label Extension Period
Withdrawal by Subject
|
1
|
1
|
3
|
|
Open-Label Extension Period
Physician Decision
|
4
|
2
|
3
|
|
Open-Label Extension Period
Lack of Efficacy
|
1
|
4
|
0
|
Baseline Characteristics
Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension
Baseline characteristics by cohort
| Measure |
Tadalafil 2.5 mg
n=142 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=140 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=140 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Total
n=422 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Male
|
142 Participants
n=93 Participants
|
140 Participants
n=4 Participants
|
140 Participants
n=27 Participants
|
422 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
142 participants
n=93 Participants
|
140 participants
n=4 Participants
|
140 participants
n=27 Participants
|
422 participants
n=483 Participants
|
|
Region of Enrollment
Japan
|
142 participants
n=93 Participants
|
140 participants
n=4 Participants
|
140 participants
n=27 Participants
|
422 participants
n=483 Participants
|
|
Baseline (Visit 3) Benign Prostatic Hyperplasia Severity
Moderate
|
100 participants
n=93 Participants
|
102 participants
n=4 Participants
|
100 participants
n=27 Participants
|
302 participants
n=483 Participants
|
|
Age Continuous
|
66.4 years
STANDARD_DEVIATION 7.4 • n=93 Participants
|
66.9 years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
67.0 years
STANDARD_DEVIATION 6.9 • n=27 Participants
|
66.8 years
STANDARD_DEVIATION 7.3 • n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Baseline (Visit 3) Benign Prostatic Hyperplasia Severity
Severe
|
42 participants
n=93 Participants
|
38 participants
n=4 Participants
|
40 participants
n=27 Participants
|
120 participants
n=483 Participants
|
|
Current Alcohol Use
Yes
|
96 participants
n=93 Participants
|
92 participants
n=4 Participants
|
93 participants
n=27 Participants
|
281 participants
n=483 Participants
|
|
Current Alcohol Use
No
|
46 participants
n=93 Participants
|
48 participants
n=4 Participants
|
47 participants
n=27 Participants
|
141 participants
n=483 Participants
|
|
Current Tobacco Use
Yes
|
31 participants
n=93 Participants
|
28 participants
n=4 Participants
|
25 participants
n=27 Participants
|
84 participants
n=483 Participants
|
|
Current Tobacco Use
No
|
61 participants
n=93 Participants
|
72 participants
n=4 Participants
|
70 participants
n=27 Participants
|
203 participants
n=483 Participants
|
|
Current Tobacco Use
Unknown or Not Recorded
|
50 participants
n=93 Participants
|
40 participants
n=4 Participants
|
45 participants
n=27 Participants
|
135 participants
n=483 Participants
|
|
Previous Alpha-blocker Use
Yes
|
111 participants
n=93 Participants
|
108 participants
n=4 Participants
|
106 participants
n=27 Participants
|
325 participants
n=483 Participants
|
|
Previous Alpha-blocker Use
No
|
31 participants
n=93 Participants
|
32 participants
n=4 Participants
|
34 participants
n=27 Participants
|
97 participants
n=483 Participants
|
|
Previous Benign Prostatic Hyperplasia Therapy
Yes
|
27 participants
n=93 Participants
|
33 participants
n=4 Participants
|
23 participants
n=27 Participants
|
83 participants
n=483 Participants
|
|
Previous Benign Prostatic Hyperplasia Therapy
No
|
115 participants
n=93 Participants
|
107 participants
n=4 Participants
|
117 participants
n=27 Participants
|
339 participants
n=483 Participants
|
|
Previous Overactive Bladder Therapy
Yes
|
10 participants
n=93 Participants
|
12 participants
n=4 Participants
|
7 participants
n=27 Participants
|
29 participants
n=483 Participants
|
|
Previous Overactive Bladder Therapy
No
|
132 participants
n=93 Participants
|
128 participants
n=4 Participants
|
133 participants
n=27 Participants
|
393 participants
n=483 Participants
|
|
Body Mass Index
|
23.3 kilograms/meters squared
STANDARD_DEVIATION 2.4 • n=93 Participants
|
23.5 kilograms/meters squared
STANDARD_DEVIATION 2.6 • n=4 Participants
|
23.6 kilograms/meters squared
STANDARD_DEVIATION 2.9 • n=27 Participants
|
23.5 kilograms/meters squared
STANDARD_DEVIATION 2.6 • n=483 Participants
|
|
Duration of BPH
|
4.1 years
STANDARD_DEVIATION 3.0 • n=93 Participants
|
4.5 years
STANDARD_DEVIATION 3.3 • n=4 Participants
|
4.1 years
STANDARD_DEVIATION 2.9 • n=27 Participants
|
4.2 years
STANDARD_DEVIATION 3.1 • n=483 Participants
|
|
Height
|
166.0 centimeters
STANDARD_DEVIATION 5.9 • n=93 Participants
|
166.9 centimeters
STANDARD_DEVIATION 6.1 • n=4 Participants
|
166.3 centimeters
STANDARD_DEVIATION 6.3 • n=27 Participants
|
166.4 centimeters
STANDARD_DEVIATION 6.1 • n=483 Participants
|
|
Postvoid Residual Volume
|
35.2 mililiters
STANDARD_DEVIATION 46.6 • n=93 Participants
|
32.2 mililiters
STANDARD_DEVIATION 36.4 • n=4 Participants
|
31.6 mililiters
STANDARD_DEVIATION 42.7 • n=27 Participants
|
33.0 mililiters
STANDARD_DEVIATION 42.1 • n=483 Participants
|
|
Weight
|
64.4 kilograms
STANDARD_DEVIATION 8.6 • n=93 Participants
|
65.4 kilograms
STANDARD_DEVIATION 8.3 • n=4 Participants
|
65.4 kilograms
STANDARD_DEVIATION 10.2 • n=27 Participants
|
65.1 kilograms
STANDARD_DEVIATION 9.1 • n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=142 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=140 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=139 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint
|
-4.5 units on a scale
Standard Error 0.4
|
-4.9 units on a scale
Standard Error 0.4
|
-3.8 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.
IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=142 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=140 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=139 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint
|
-1.6 units on a scale
Standard Error 0.2
|
-1.6 units on a scale
Standard Error 0.2
|
-1.4 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=142 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=140 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=139 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint
|
-2.9 units on a scale
Standard Error 0.3
|
-3.3 units on a scale
Standard Error 0.3
|
-2.4 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.
Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=142 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=140 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=139 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint
|
-0.5 units on a scale
Standard Error 0.1
|
-0.7 units on a scale
Standard Error 0.1
|
-0.4 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.
The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=142 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=140 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=139 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint
|
-0.7 units on a scale
Standard Error 0.1
|
-0.8 units on a scale
Standard Error 0.1
|
-0.7 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.
Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=140 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=135 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=136 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint
|
0.7 milliliters per second
Standard Error 0.3
|
0.6 milliliters per second
Standard Error 0.3
|
1.4 milliliters per second
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants who received 2.5 mg or 5 mg tadalafil once daily during the double-blind period.
Plasma from participants in the tadalafil treatment groups were assayed using a validated liquid chromatographic/mass spectrometric (LC/MS) method.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=135 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=128 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement
0-6 hours (n=225, 200)
|
86.0 nanogram/milliliter
Standard Deviation 44.0
|
169 nanogram/milliliter
Standard Deviation 41.2
|
—
|
|
Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement
6-12 hours (n=72, 72)
|
68.7 nanogram/milliliter
Standard Deviation 37.6
|
140 nanogram/milliliter
Standard Deviation 51.3
|
—
|
|
Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement
12-24 hours (n=102, 106)
|
57.5 nanogram/milliliter
Standard Deviation 49.1
|
93.6 nanogram/milliliter
Standard Deviation 55.6
|
—
|
|
Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement
24-48 hours (n=11, 8)
|
43.5 nanogram/milliliter
Standard Deviation 89.7
|
75.2 nanogram/milliliter
Standard Deviation 56.0
|
—
|
SECONDARY outcome
Timeframe: Baseline through 12 weeksPopulation: All randomized participants
A listing of Adverse Events are reported in the Reported Adverse Event Section.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=142 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=140 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=140 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Number of Participants With Adverse Events During 12 Weeks of the Study
Serious Adverse Events
|
2 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Adverse Events During 12 Weeks of the Study
Non-Serious Adverse Events
|
52 participants
|
54 participants
|
53 participants
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=142 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=140 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=139 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in Blood Pressure at 12-Week Endpoint
Systolic Blood Pressure
|
-2.0 mmHg
Standard Deviation 11.9
|
-3.4 mmHg
Standard Deviation 12.2
|
-0.5 mmHg
Standard Deviation 14.0
|
|
Change From Baseline in Blood Pressure at 12-Week Endpoint
Diastolic Blood Pressure
|
-0.7 mmHg
Standard Deviation 9.5
|
-2.9 mmHg
Standard Deviation 8.3
|
-0.9 mmHg
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=142 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=140 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=139 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in Sitting Heart Rate at 12-Week Endpoint
|
-0.7 beats per minute
Standard Deviation 9.9
|
-1.2 beats per minute
Standard Deviation 9.8
|
0.0 beats per minute
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.
Postvoid residual volume (PVR) is measured by ultrasound at regular intervals.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=142 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=140 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=137 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint
|
-9.41 milliliters
Standard Deviation 41.43
|
-5.15 milliliters
Standard Deviation 40.32
|
-4.72 milliliters
Standard Deviation 36.40
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Safety Analysis Set: All randomized participants who received study treatment grouped by the treatment actually taken.
Measurement of nanograms of PSA per milliliter (ng/mL) of blood.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=142 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=138 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=139 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint
|
0.26 Micrograms per liter
Standard Deviation 1.54
|
0.09 Micrograms per liter
Standard Deviation 0.88
|
0.14 Micrograms per liter
Standard Deviation 2.90
|
SECONDARY outcome
Timeframe: Baseline, 54 weeksPopulation: All participants enrolled in the open-label extension period who received at least 1 dose of tadalafil.
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=135 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=128 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=131 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint
|
-5.2 units on a scale
Standard Deviation 5.9
|
-5.4 units on a scale
Standard Deviation 6.3
|
-6.2 units on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline, 54 weeksPopulation: All participants enrolled in the open-label extension period who received at least 1 dose of tadalafil.
IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=135 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=128 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=131 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint
|
-1.9 units on a scale
Standard Deviation 2.5
|
-1.6 units on a scale
Standard Deviation 2.8
|
-1.8 units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline, 54 weeksPopulation: All participants enrolled in the open-label phase who received at least 1 dose of tadalafil.
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=135 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=128 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=131 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint
|
-3.4 units on a scale
Standard Deviation 4.1
|
-3.7 units on a scale
Standard Deviation 4.5
|
-4.3 units on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Baseline, 54 weeksPopulation: All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.
Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=135 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=128 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=131 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint
|
-0.8 units on a scale
Standard Deviation 1.2
|
-1.0 units on a scale
Standard Deviation 1.4
|
-0.9 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline, 54 weeksPopulation: All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.
The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=135 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=128 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=131 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint
|
-0.9 units on a scale
Standard Deviation 2.0
|
-1.0 units on a scale
Standard Deviation 2.4
|
-0.9 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline, 54 weeksPopulation: All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.
Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=134 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=128 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=127 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint
|
2.29 units on a scale
Standard Deviation 4.29
|
1.51 units on a scale
Standard Deviation 4.48
|
2.01 units on a scale
Standard Deviation 5.05
|
SECONDARY outcome
Timeframe: End of 12 weeks of double-blind through 54 weeksPopulation: All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.
A listing of Adverse Events are reported in the Reported Adverse Event Section.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=135 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=128 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=131 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment
Serious Adverse Events
|
3 participants
|
4 participants
|
4 participants
|
|
Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment
Non-Serious Adverse Events
|
81 participants
|
81 participants
|
94 participants
|
SECONDARY outcome
Timeframe: Baseline, 54 weeksPopulation: All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=135 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=128 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=131 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in Blood Pressure During at 54-Week Endpoint
Systolic blood pressure
|
-2.1 millimeters of mercury (mmHg)
Standard Deviation 13.4
|
-1.2 millimeters of mercury (mmHg)
Standard Deviation 13.2
|
-0.5 millimeters of mercury (mmHg)
Standard Deviation 14.2
|
|
Change From Baseline in Blood Pressure During at 54-Week Endpoint
Diastolic blood pressure
|
-1.6 millimeters of mercury (mmHg)
Standard Deviation 9.6
|
-2.9 millimeters of mercury (mmHg)
Standard Deviation 9.2
|
-1.3 millimeters of mercury (mmHg)
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: Baseline, 54-weeksPopulation: All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=135 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=128 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=131 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in Sitting Heart Rate at 54-Week Endpoint
|
1.4 beats per minute (bpm)
Standard Deviation 10.4
|
0.4 beats per minute (bpm)
Standard Deviation 9.3
|
2.1 beats per minute (bpm)
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Baseline, 54 weeksPopulation: All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.
Measurement of nanograms of PSA per milliliter (ng/mL) of blood.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=135 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=127 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=129 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint
|
0.4 microgram/liter
Standard Deviation 1.0
|
0.3 microgram/liter
Standard Deviation 0.9
|
0.3 microgram/liter
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline, 54 weeksPopulation: All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.
Post residual volume (PVR) is measured by ultrasound at regular intervals.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=135 Participants
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Tadalafil 5 mg
n=128 Participants
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
Placebo
n=131 Participants
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
|
|---|---|---|---|
|
Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint
|
-5.7 milliliter
Standard Deviation 50.0
|
-1.9 milliliter
Standard Deviation 42.9
|
-5.5 milliliter
Standard Deviation 46.8
|
Adverse Events
Tadalafil 2.5 mg - Double-Blind Phase
Serious events: 2 serious events
Other events: 52 other events
Deaths: 0 deaths
Tadalafil 5 mg - Double-Blind Phase
Serious events: 2 serious events
Other events: 54 other events
Deaths: 0 deaths
Placebo - Double-Blind Phase
Serious events: 1 serious events
Other events: 53 other events
Deaths: 0 deaths
Tadalafil 2.5 mg: Tadalafil 5 mg Open-Label
Serious events: 3 serious events
Other events: 81 other events
Deaths: 0 deaths
Tadalafil 5 mg: Tadalafil 5 mg Open-Label
Serious events: 4 serious events
Other events: 81 other events
Deaths: 0 deaths
Placebo: Tadalafil 5 mg Open-Label
Serious events: 4 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tadalafil 2.5 mg - Double-Blind Phase
n=142 participants at risk
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks in the Open-Label Phase.
|
Tadalafil 5 mg - Double-Blind Phase
n=140 participants at risk
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks during the Open-Label Phase.
|
Placebo - Double-Blind Phase
n=140 participants at risk
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks during the Open-Label Phase.
|
Tadalafil 2.5 mg: Tadalafil 5 mg Open-Label
n=135 participants at risk
5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received 2.5 mg tadalafil in the double-blind phase.
|
Tadalafil 5 mg: Tadalafil 5 mg Open-Label
n=128 participants at risk
5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received 5 mg tadalafil in the double-blind phase.
|
Placebo: Tadalafil 5 mg Open-Label
n=131 participants at risk
5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received placebo in the double-blind phase.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Infections and infestations
Appendicitis
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.76%
1/131 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.76%
1/131 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.78%
1/128 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Injury, poisoning and procedural complications
Traumatic arthritis
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.78%
1/128 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.78%
1/128 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.76%
1/131 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.76%
1/131 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.76%
1/131 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.78%
1/128 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
Other adverse events
| Measure |
Tadalafil 2.5 mg - Double-Blind Phase
n=142 participants at risk
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks in the Open-Label Phase.
|
Tadalafil 5 mg - Double-Blind Phase
n=140 participants at risk
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks during the Open-Label Phase.
|
Placebo - Double-Blind Phase
n=140 participants at risk
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks during the Open-Label Phase.
|
Tadalafil 2.5 mg: Tadalafil 5 mg Open-Label
n=135 participants at risk
5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received 2.5 mg tadalafil in the double-blind phase.
|
Tadalafil 5 mg: Tadalafil 5 mg Open-Label
n=128 participants at risk
5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received 5 mg tadalafil in the double-blind phase.
|
Placebo: Tadalafil 5 mg Open-Label
n=131 participants at risk
5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received placebo in the double-blind phase.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Cardiac disorders
Palpitations
|
2.1%
3/142 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Ear and labyrinth disorders
Vertigo
|
1.4%
2/142 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Eye disorders
Cataract
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.1%
3/140 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
3.0%
4/135 • Number of events 4 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.3%
3/128 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.5%
2/131 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Eye disorders
Eye discharge
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Eye disorders
Macular hole
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Eye disorders
Vision blurred
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.3%
3/128 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.76%
1/131 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.3%
3/128 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.5%
2/131 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
3/142 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
3.6%
5/140 • Number of events 5 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
5.9%
8/135 • Number of events 16 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
8.6%
11/128 • Number of events 12 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
9.2%
12/131 • Number of events 13 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Dry mouth
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.4%
2/142 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.9%
4/140 • Number of events 4 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
3.0%
4/135 • Number of events 4 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
4.7%
6/128 • Number of events 7 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
3.8%
5/131 • Number of events 6 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.2%
3/135 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
2/142 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
3.7%
5/135 • Number of events 5 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.6%
2/128 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.3%
3/131 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Gingivitis
|
2.1%
3/142 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
3.0%
4/135 • Number of events 5 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.78%
1/128 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Periodontitis
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Periproctitis
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
2.1%
3/142 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
3.7%
5/135 • Number of events 5 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
3.1%
4/128 • Number of events 4 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
3.1%
4/131 • Number of events 4 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Stomatitis
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Toothache
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
General disorders
Chest pain
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
General disorders
Cyst
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
General disorders
Oedema
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
General disorders
Pyrexia
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
General disorders
Thirst
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
General disorders
Xerosis
|
1.4%
2/142 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Immune system disorders
Seasonal allergy
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.5%
2/135 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.78%
1/128 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
3.8%
5/131 • Number of events 5 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Infections and infestations
Empyema
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Infections and infestations
Herpes zoster
|
1.4%
2/142 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Infections and infestations
Influenza
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
11/142 • Number of events 11 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
10.0%
14/140 • Number of events 14 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
12.9%
18/140 • Number of events 19 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
18.5%
25/135 • Number of events 28 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
11.7%
15/128 • Number of events 17 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
14.5%
19/131 • Number of events 31 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Infections and infestations
Otitis media
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Infections and infestations
Pharyngitis
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.3%
3/131 • Number of events 5 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Infections and infestations
Tinea infection
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.4%
2/142 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.3%
3/128 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Investigations
Occult blood positive
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Investigations
Tumour marker increased
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.6%
2/128 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
5.3%
7/131 • Number of events 7 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
2/142 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
3.7%
5/135 • Number of events 5 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
3.9%
5/128 • Number of events 5 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
6.1%
8/131 • Number of events 8 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.2%
3/135 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.6%
2/128 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
3.1%
4/128 • Number of events 4 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Nervous system disorders
Headache
|
1.4%
2/142 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.1%
3/140 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.1%
3/140 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.5%
2/135 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.3%
3/128 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
6.9%
9/131 • Number of events 9 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Nervous system disorders
Hypoaesthesia
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Nervous system disorders
Sciatica
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.2%
3/135 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.78%
1/128 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
3.1%
4/131 • Number of events 4 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.2%
3/135 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.3%
3/128 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Reproductive system and breast disorders
Nipple disorder
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.3%
3/128 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.78%
1/128 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.3%
3/131 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.1%
3/140 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.5%
2/135 • Number of events 4 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.3%
3/128 • Number of events 4 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
4.6%
6/131 • Number of events 6 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Surgical and medical procedures
Colon polypectomy
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Surgical and medical procedures
Dental implantation
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Surgical and medical procedures
Gastrointestinal tube insertion
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Surgical and medical procedures
Internal fixation of fracture
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Surgical and medical procedures
Tooth extraction
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.2%
3/135 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.76%
1/131 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Surgical and medical procedures
Ureteral catheterisation
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Vascular disorders
Flushing
|
0.70%
1/142 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Vascular disorders
Hot flush
|
2.1%
3/142 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.4%
2/140 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.5%
2/135 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.6%
2/128 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.3%
3/131 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Vascular disorders
Hypertension
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.71%
1/140 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/128 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.3%
3/128 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.6%
2/128 • Number of events 2 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
2.3%
3/131 • Number of events 3 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
1.5%
2/135 • Number of events 5 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
3.1%
4/128 • Number of events 4 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.76%
1/131 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/142 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/140 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
3.1%
4/128 • Number of events 4 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
0.00%
0/131 • Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60