Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention (NCT NCT01952574)
NCT ID: NCT01952574
Last Updated: 2022-10-12
Results Overview
A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura. The change from baseline in monthly migraine days was calculated as the number of migraine days during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine days during the 4-week baseline phase.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
483 participants
Primary outcome timeframe
4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
Results posted on
2022-10-12
Participant Flow
This study was conducted at 59 centers in North America (Canada, USA) and Europe (Denmark, Finland, Germany, Norway, Sweden, and Portugal). The study consisted of a 12-week double-blind treatment phase (DBTP) and a 256-week open-label treatment phase (OLTP) followed by a safety follow-up of 8 to 12 weeks (12 -16 weeks after last dose). The OLTP portion of the study was not conducted in Norway.
Participants were randomized 3:2:2:2 to receive placebo, erenumab 7 mg, erenumab 21 mg, or erenumab 70 mg once a month (QM) in the double-blind phase. Randomization was stratified by region (North America vs. Europe). During the open-label treatment phase, participants in the United States (US) could participate in an optional Clinical Home Use (CHU) substudy.
Participant milestones
| Measure |
DBTP: Placebo QM
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
DBTP: Erenumab 7 mg QM
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
DBTP: Erenumab 21 mg QM
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
DBTP: Erenumab 70 mg QM
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
OLTP: Erenumab 70/140 mg QM
Participants received 70 mg erenumab QM from the beginning of the OLTP (week 12). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
|
CHU Substudy: Erenumab 140 mg by Prefilled Syringe
Participants in the open-label treatment phase in the United States randomized to self-administer 140 mg erenumab via two 70 mg injections using a prefilled syringe (PFS) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
|
CHU Substudy: Erenumab 140 mg Autoinjector/Pen
Participants in the open-label treatment phase in the United States randomized to self-administer 140 mg erenumab via two 70 mg injections using an autoinjector (AI)/pen on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
|
|---|---|---|---|---|---|---|---|
|
Double-blind Treatment Phase
STARTED
|
160
|
108
|
108
|
107
|
0
|
0
|
0
|
|
Double-blind Treatment Phase
Received Study Drug
|
153
|
108
|
105
|
106
|
0
|
0
|
0
|
|
Double-blind Treatment Phase
COMPLETED
|
143
|
105
|
99
|
101
|
0
|
0
|
0
|
|
Double-blind Treatment Phase
NOT COMPLETED
|
17
|
3
|
9
|
6
|
0
|
0
|
0
|
|
Open-label Treatment Phase
STARTED
|
0
|
0
|
0
|
0
|
383
|
0
|
0
|
|
Open-label Treatment Phase
Received 70 mg Erenumab
|
0
|
0
|
0
|
0
|
383
|
0
|
0
|
|
Open-label Treatment Phase
Received 140 mg Erenumab
|
0
|
0
|
0
|
0
|
250
|
0
|
0
|
|
Open-label Treatment Phase
COMPLETED
|
0
|
0
|
0
|
0
|
221
|
0
|
0
|
|
Open-label Treatment Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
162
|
0
|
0
|
|
Clinical Home Use Substudy
STARTED
|
0
|
0
|
0
|
0
|
0
|
42
|
41
|
|
Clinical Home Use Substudy
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
39
|
40
|
|
Clinical Home Use Substudy
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
Reasons for withdrawal
| Measure |
DBTP: Placebo QM
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
DBTP: Erenumab 7 mg QM
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
DBTP: Erenumab 21 mg QM
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
DBTP: Erenumab 70 mg QM
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
OLTP: Erenumab 70/140 mg QM
Participants received 70 mg erenumab QM from the beginning of the OLTP (week 12). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
|
CHU Substudy: Erenumab 140 mg by Prefilled Syringe
Participants in the open-label treatment phase in the United States randomized to self-administer 140 mg erenumab via two 70 mg injections using a prefilled syringe (PFS) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
|
CHU Substudy: Erenumab 140 mg Autoinjector/Pen
Participants in the open-label treatment phase in the United States randomized to self-administer 140 mg erenumab via two 70 mg injections using an autoinjector (AI)/pen on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
|
|---|---|---|---|---|---|---|---|
|
Double-blind Treatment Phase
Withdrawal by Subject
|
9
|
3
|
3
|
4
|
0
|
0
|
0
|
|
Double-blind Treatment Phase
Sponsor Decision
|
6
|
0
|
5
|
2
|
0
|
0
|
0
|
|
Double-blind Treatment Phase
Lost to Follow-up
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Open-label Treatment Phase
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
121
|
0
|
0
|
|
Open-label Treatment Phase
Decision by Sponsor
|
0
|
0
|
0
|
0
|
17
|
0
|
0
|
|
Open-label Treatment Phase
Missing
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
|
Open-label Treatment Phase
Lost to Follow-up
|
0
|
0
|
0
|
0
|
19
|
0
|
0
|
|
Open-label Treatment Phase
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Clinical Home Use Substudy
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Clinical Home Use Substudy
Decision by Sponsor
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
Baseline Characteristics
Participants with available baseline data
Baseline characteristics by cohort
| Measure |
Placebo
n=160 Participants
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 7 mg QM
n=108 Participants
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 21 mg QM
n=108 Participants
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 70 mg QM
n=107 Participants
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Total
n=483 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
41.4 years
STANDARD_DEVIATION 10.0 • n=160 Participants
|
40.3 years
STANDARD_DEVIATION 10.9 • n=108 Participants
|
39.9 years
STANDARD_DEVIATION 12.3 • n=108 Participants
|
42.6 years
STANDARD_DEVIATION 9.9 • n=107 Participants
|
41.1 years
STANDARD_DEVIATION 10.8 • n=483 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=160 Participants
|
88 Participants
n=108 Participants
|
87 Participants
n=108 Participants
|
82 Participants
n=107 Participants
|
389 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=160 Participants
|
20 Participants
n=108 Participants
|
21 Participants
n=108 Participants
|
25 Participants
n=107 Participants
|
94 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=160 Participants
|
9 Participants
n=108 Participants
|
9 Participants
n=108 Participants
|
1 Participants
n=107 Participants
|
30 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
149 Participants
n=160 Participants
|
99 Participants
n=108 Participants
|
99 Participants
n=108 Participants
|
106 Participants
n=107 Participants
|
453 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=160 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=160 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=160 Participants
|
0 Participants
n=108 Participants
|
1 Participants
n=108 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
13 Participants
n=160 Participants
|
10 Participants
n=108 Participants
|
7 Participants
n=108 Participants
|
2 Participants
n=107 Participants
|
32 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=160 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
142 Participants
n=160 Participants
|
97 Participants
n=108 Participants
|
100 Participants
n=108 Participants
|
103 Participants
n=107 Participants
|
442 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=160 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=108 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=160 Participants
|
1 Participants
n=108 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=483 Participants
|
|
Region
North America
|
85 Participants
n=160 Participants
|
58 Participants
n=108 Participants
|
58 Participants
n=108 Participants
|
58 Participants
n=107 Participants
|
259 Participants
n=483 Participants
|
|
Region
Europe
|
75 Participants
n=160 Participants
|
50 Participants
n=108 Participants
|
50 Participants
n=108 Participants
|
49 Participants
n=107 Participants
|
224 Participants
n=483 Participants
|
|
Monthly Migraine Days
|
8.77 migraine days/month
STANDARD_DEVIATION 2.72 • n=160 Participants • Participants with available baseline data
|
8.62 migraine days/month
STANDARD_DEVIATION 2.79 • n=108 Participants • Participants with available baseline data
|
8.93 migraine days/month
STANDARD_DEVIATION 2.88 • n=108 Participants • Participants with available baseline data
|
8.58 migraine days/month
STANDARD_DEVIATION 2.49 • n=106 Participants • Participants with available baseline data
|
8.73 migraine days/month
STANDARD_DEVIATION 2.72 • n=482 Participants • Participants with available baseline data
|
PRIMARY outcome
Timeframe: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phasePopulation: Participants who received at least 1 dose of investigational product (IP) and had ≥ 4 migraine days during the 4-week baseline phase (efficacy analysis set), and with at least one change from baseline value in monthly migraine days.
A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura. The change from baseline in monthly migraine days was calculated as the number of migraine days during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine days during the 4-week baseline phase.
Outcome measures
| Measure |
Placebo
n=152 Participants
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 7 mg QM
n=107 Participants
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 21 mg QM
n=99 Participants
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 70 mg QM
n=104 Participants
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
|---|---|---|---|---|
|
Change From Baseline in Monthly Migraine Days at Week 12
|
-2.28 migraine days / month
Standard Error 0.31
|
-2.18 migraine days / month
Standard Error 0.36
|
-2.39 migraine days / month
Standard Error 0.38
|
-3.40 migraine days / month
Standard Error 0.37
|
PRIMARY outcome
Timeframe: CHU substudy day 29 (week 4) and day 57 (week 8)Population: Participants enrolled in the CHU substudy who received at least 1 dose of investigational product in the substudy.
To assess participants ability to administer a full dose of erenumab in home-use at day 29 (week 4) and day 57 (week 8), site staff called participants and asked whether the participant administered a full, partial, or no dose of erenumab. A full dose means that the entire volume of both prefilled syringes or autoinjector/pens were injected. Discontinued prior to dosing day indicates participants who had discontinued the investigational product and did not attempt to self-administer on day 29 or 57.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 7 mg QM
n=41 Participants
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 21 mg QM
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 70 mg QM
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
|---|---|---|---|---|
|
CHU Substudy: Number of Participants Who Self-administered a Full Dose, Partial Dose, or No Dose of Erenumab
Day 29 (week 4) · Full dose
|
39 Participants
|
41 Participants
|
—
|
—
|
|
CHU Substudy: Number of Participants Who Self-administered a Full Dose, Partial Dose, or No Dose of Erenumab
Day 29 (week 4) · Partial dose
|
1 Participants
|
0 Participants
|
—
|
—
|
|
CHU Substudy: Number of Participants Who Self-administered a Full Dose, Partial Dose, or No Dose of Erenumab
Day 29 (week 4) · Discontinued prior to dosing day
|
2 Participants
|
0 Participants
|
—
|
—
|
|
CHU Substudy: Number of Participants Who Self-administered a Full Dose, Partial Dose, or No Dose of Erenumab
Day 57 (week 8) · Full dose
|
39 Participants
|
39 Participants
|
—
|
—
|
|
CHU Substudy: Number of Participants Who Self-administered a Full Dose, Partial Dose, or No Dose of Erenumab
Day 57 (week 8) · Partial dose
|
0 Participants
|
1 Participants
|
—
|
—
|
|
CHU Substudy: Number of Participants Who Self-administered a Full Dose, Partial Dose, or No Dose of Erenumab
Day 57 (week 8) · Discontinued prior to dosing day
|
3 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phasePopulation: Participants who received at least 1 dose of investigational product and had ≥ 4 migraine days during the 4-week baseline phase (efficacy analysis set) with available data at week 12.
A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the last 4 weeks of double-blind treatment. At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 4 weeks of the 12-week double-blind treatment phase \* 100 / baseline monthly migraine days was less than or equal to -50%.
Outcome measures
| Measure |
Placebo
n=144 Participants
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 7 mg QM
n=104 Participants
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 21 mg QM
n=93 Participants
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 70 mg QM
n=99 Participants
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Week 12
|
29.9 percentage of participants
|
28.8 percentage of participants
|
34.4 percentage of participants
|
46.5 percentage of participants
|
SECONDARY outcome
Timeframe: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phasePopulation: Participants who received at least 1 dose of investigational product and had ≥ 4 migraine days during the 4-week baseline phase (efficacy analysis set), and with at least one change from baseline value in monthly migraine attacks.
A migraine attack is an episode of any qualified migraine headache or migraine specific medication intakes for aura only. A migraine attack that was interrupted by sleep or that temporarily remits and then recurs within 48 hours or an attack treated successfully with medication but that relapses within 48 hours was considered to be one attack. The change from baseline in monthly migraine attacks was calculated as the number of migraine attacks during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine attacks during the 4-week baseline phase.
Outcome measures
| Measure |
Placebo
n=152 Participants
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 7 mg QM
n=107 Participants
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 21 mg QM
n=99 Participants
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 70 mg QM
n=104 Participants
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
|---|---|---|---|---|
|
Change From Baseline in Monthly Migraine Attacks at Week 12
|
-1.44 migraine attacks/month
Standard Error 0.17
|
-1.07 migraine attacks/month
Standard Error 0.20
|
-1.42 migraine attacks/month
Standard Error 0.21
|
-1.84 migraine attacks/month
Standard Error 0.20
|
SECONDARY outcome
Timeframe: From first dose of study drug in the double-blind treatment phase until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase.Population: Randomized participants who received at least one dose of investigational product (safety analysis set).
An adverse event (AE) is any untoward medical occurrence in a clinical trial subject, including worsening of a pre-existing medical condition and laboratory value changes that require treatment or adjustment in current therapy. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: 1. Mild; asymptomatic or mild symptoms 2. Moderate; minimal, local or noninvasive intervention indicated; limiting daily activities 3. Severe or medically significant but not immediately life-threatening; hospitalization indicated; disabling; limiting self-care 4. Life-threatening consequences; urgent intervention indicated 5. Death related to AE A serious adverse event is an AE that meets at least 1 of the following criteria: * fatal * life threatening * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event
Outcome measures
| Measure |
Placebo
n=153 Participants
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 7 mg QM
n=108 Participants
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 21 mg QM
n=105 Participants
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 70 mg QM
n=106 Participants
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events in the Double-blind Treatment Phase
Any adverse event (AE)
|
81 Participants
|
57 Participants
|
55 Participants
|
57 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events in the Double-blind Treatment Phase
Serious adverse events (SAEs)
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events in the Double-blind Treatment Phase
AE leading to discontinuation of IP
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events in the Double-blind Treatment Phase
AE Grade ≥ 2
|
36 Participants
|
31 Participants
|
25 Participants
|
23 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events in the Double-blind Treatment Phase
AE Grade ≥ 3
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events in the Double-blind Treatment Phase
AE Grade ≥ 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events in the Double-blind Treatment Phase
Fatal adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose in the open-label treatment phase up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; a maximum of 268 weeks.Population: All participants who received at least one dose of investigational product in the open-label treatment phase (open-label treatment phase set).
An adverse event (AE) is any untoward medical occurrence in a clinical trial subject, including worsening of a pre-existing medical condition and laboratory value changes that require treatment or adjustment in current therapy. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: 1. Mild; asymptomatic or mild symptoms 2. Moderate; minimal, local or noninvasive intervention indicated; limiting daily activities 3. Severe or medically significant but not immediately life-threatening; hospitalization indicated; disabling; limiting self-care 4. Life-threatening consequences; urgent intervention indicated 5. Death related to AE A serious adverse event is an AE that meets at least 1 of the following criteria: * fatal * life threatening * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event
Outcome measures
| Measure |
Placebo
n=383 Participants
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 7 mg QM
n=250 Participants
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 21 mg QM
n=383 Participants
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 70 mg QM
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events in the Open-label Treatment Phase
AE Grade ≥ 2
|
249 Participants
|
180 Participants
|
286 Participants
|
—
|
|
Number of Participants With Treatment-emergent Adverse Events in the Open-label Treatment Phase
Any adverse event (AE)
|
323 Participants
|
216 Participants
|
340 Participants
|
—
|
|
Number of Participants With Treatment-emergent Adverse Events in the Open-label Treatment Phase
Serious adverse events (SAEs)
|
30 Participants
|
25 Participants
|
49 Participants
|
—
|
|
Number of Participants With Treatment-emergent Adverse Events in the Open-label Treatment Phase
AE leading to discontinuation of IP
|
16 Participants
|
2 Participants
|
18 Participants
|
—
|
|
Number of Participants With Treatment-emergent Adverse Events in the Open-label Treatment Phase
AE Grade ≥ 3
|
55 Participants
|
40 Participants
|
83 Participants
|
—
|
|
Number of Participants With Treatment-emergent Adverse Events in the Open-label Treatment Phase
AE Grade ≥ 4
|
1 Participants
|
3 Participants
|
4 Participants
|
—
|
|
Number of Participants With Treatment-emergent Adverse Events in the Open-label Treatment Phase
Fatal adverse events
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: From first dose in the CHU substudy to end of substudy (up to 12 weeks)Population: Participants enrolled in the CHU substudy who received at least 1 dose of investigational product in the substudy.
AEs were graded using the CTCAE version 4.03: 1. Mild; asymptomatic or mild symptoms 2. Moderate; minimal, local or noninvasive intervention indicated; limiting daily activities 3. Severe or medically significant but not immediately life-threatening; hospitalization indicated; disabling; limiting self-care 4. Life-threatening consequences; urgent intervention indicated 5. Death related to AE A serious adverse event is an AE that meets at least 1 of the following criteria: * fatal * life threatening * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event An adverse device effect is any AE related to the use of a medical device, including AEs resulting from insufficient or inadequate instructions for use, any malfunction of the device, or use error or from intentional misuse of the device.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 7 mg QM
n=41 Participants
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 21 mg QM
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 70 mg QM
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
|---|---|---|---|---|
|
CHU Substudy: Number of Participants With Treatment-emergent Adverse Events During the CHU Substudy
Any adverse event
|
13 Participants
|
17 Participants
|
—
|
—
|
|
CHU Substudy: Number of Participants With Treatment-emergent Adverse Events During the CHU Substudy
AE Grade ≥ 2
|
7 Participants
|
10 Participants
|
—
|
—
|
|
CHU Substudy: Number of Participants With Treatment-emergent Adverse Events During the CHU Substudy
AE Grade ≥ 3
|
1 Participants
|
2 Participants
|
—
|
—
|
|
CHU Substudy: Number of Participants With Treatment-emergent Adverse Events During the CHU Substudy
AE Grade ≥ 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
CHU Substudy: Number of Participants With Treatment-emergent Adverse Events During the CHU Substudy
Serious adverse events
|
0 Participants
|
0 Participants
|
—
|
—
|
|
CHU Substudy: Number of Participants With Treatment-emergent Adverse Events During the CHU Substudy
Leading to discontinuation of IP
|
0 Participants
|
0 Participants
|
—
|
—
|
|
CHU Substudy: Number of Participants With Treatment-emergent Adverse Events During the CHU Substudy
Fatal adverse events
|
0 Participants
|
0 Participants
|
—
|
—
|
|
CHU Substudy: Number of Participants With Treatment-emergent Adverse Events During the CHU Substudy
Injection site reactions
|
4 Participants
|
2 Participants
|
—
|
—
|
|
CHU Substudy: Number of Participants With Treatment-emergent Adverse Events During the CHU Substudy
Adverse device effects
|
2 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants who received at least 1 dose of IP and with valid postbaseline antibody testing results.
Two validated assays were used to detect the presence of anti-erenumab antibodies. First, an electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding erenumab. Second, a cell-based bioassay was used to test positive binding antibody samples for neutralizing activity against erenumab. Participants who developed anti-erenumab antibodies are participants who were negative or had no result at baseline but positive at any time postbaseline during the DBTP. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the participant was defined as positive for neutralizing antibodies.
Outcome measures
| Measure |
Placebo
n=149 Participants
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 7 mg QM
n=107 Participants
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 21 mg QM
n=104 Participants
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 70 mg QM
n=106 Participants
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
|---|---|---|---|---|
|
Number of Participants Who Developed Anti-erenumab Antibodies During the Double-blind Treatment Phase
Developed binding antibodies
|
0 Participants
|
13 Participants
|
12 Participants
|
8 Participants
|
|
Number of Participants Who Developed Anti-erenumab Antibodies During the Double-blind Treatment Phase
Developed neutralizing antibodies
|
0 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From week 12 up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks.Population: Participants who received at least 1 dose of IP in the OLTP and with valid antibody testing results during the OLTP.
Two validated assays were used to detect the presence of anti-erenumab antibodies. First, an electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding erenumab. Second, a cell-based bioassay was used to test positive binding antibody samples for neutralizing activity against erenumab. Participants who developed anti-erenumab antibodies are participants who were negative prior to the first OLTP dose but positive at any time during the OLTP, or participants with no data prior to first dose in OLTP with any post-baseline positive results. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the participant was defined as positive for neutralizing antibodies.
Outcome measures
| Measure |
Placebo
n=119 Participants
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 7 mg QM
n=88 Participants
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 21 mg QM
n=87 Participants
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
Erenumab 70 mg QM
n=86 Participants
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
|---|---|---|---|---|
|
Number of Participants Who Developed Anti-erenumab Antibodies During the Open-label Treatment Phase
Developed binding antibodies
|
12 Participants
|
8 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants Who Developed Anti-erenumab Antibodies During the Open-label Treatment Phase
Developed neutralizing antibodies
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
DBTP: Placebo QM
Serious events: 1 serious events
Other events: 45 other events
Deaths: 0 deaths
DBTP: Erenumab 7 mg QM
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
DBTP: Erenumab 21 mg QM
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
DBTP: Erenumab 70 mg QM
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
OLTP: Erenumab 70 mg QM
Serious events: 30 serious events
Other events: 220 other events
Deaths: 0 deaths
OLTP: Erenumab 140 mg QM
Serious events: 25 serious events
Other events: 172 other events
Deaths: 0 deaths
OLTP: Erenumab 70/140 mg QM
Serious events: 49 serious events
Other events: 264 other events
Deaths: 0 deaths
CHU Substudy: Erenumab 140 mg PFS
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
CHU Substudy: Erenumab 140 mg AI/Pen
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
CHU Substudy: Total
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DBTP: Placebo QM
n=153 participants at risk
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
DBTP: Erenumab 7 mg QM
n=108 participants at risk
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
DBTP: Erenumab 21 mg QM
n=105 participants at risk
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
DBTP: Erenumab 70 mg QM
n=106 participants at risk
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
OLTP: Erenumab 70 mg QM
n=383 participants at risk
Participants received 70 mg erenumab QM from week 12 until implementation of Protocol Amendment 3 (07 April 2016) in the open-label treatment phase; median duration of exposure was 104 weeks.
|
OLTP: Erenumab 140 mg QM
n=250 participants at risk
After implementation of Protocol Amendment 3 (07 April 2016), participants still on study received erenumab 140 mg QM up to week 264 in the open-label treatment phase; median duration of exposure was 141 weeks.
|
OLTP: Erenumab 70/140 mg QM
n=383 participants at risk
Participants received 70 mg erenumab QM from the beginning of the OLTP (week 12). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
|
CHU Substudy: Erenumab 140 mg PFS
n=42 participants at risk
Participants in the open-label treatment phase in the United States self-administered 140 mg erenumab via two 70 mg injections using a prefilled syringe (PFS) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
|
CHU Substudy: Erenumab 140 mg AI/Pen
n=41 participants at risk
Participants in the open-label treatment phase in the United States self-administered 140 mg erenumab via two 70 mg injections using an autoinjector/pen (AI)/pen) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
|
CHU Substudy: Total
n=83 participants at risk
Participants in the open-label treatment phase in the United States self-administered 140 mg erenumab via two 70 mg injections using a prefilled syringe or autoinjector/pen on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.94%
1/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.94%
1/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.93%
1/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Endocrine disorders
Primary hyperaldosteronism
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Eye disorders
Visual impairment
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Gastrointestinal disorders
Appendicitis noninfective
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
General disorders
Death
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.80%
2/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.52%
2/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.65%
1/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.80%
2/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.78%
3/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.52%
2/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.52%
2/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.52%
2/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage III
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.52%
2/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.52%
2/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.52%
2/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.52%
2/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Reproductive system and breast disorders
Adnexa uteri cyst
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.40%
1/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.52%
2/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Vascular disorders
Thrombosis
|
0.00%
0/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.26%
1/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
Other adverse events
| Measure |
DBTP: Placebo QM
n=153 participants at risk
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
DBTP: Erenumab 7 mg QM
n=108 participants at risk
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
DBTP: Erenumab 21 mg QM
n=105 participants at risk
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
DBTP: Erenumab 70 mg QM
n=106 participants at risk
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
|
OLTP: Erenumab 70 mg QM
n=383 participants at risk
Participants received 70 mg erenumab QM from week 12 until implementation of Protocol Amendment 3 (07 April 2016) in the open-label treatment phase; median duration of exposure was 104 weeks.
|
OLTP: Erenumab 140 mg QM
n=250 participants at risk
After implementation of Protocol Amendment 3 (07 April 2016), participants still on study received erenumab 140 mg QM up to week 264 in the open-label treatment phase; median duration of exposure was 141 weeks.
|
OLTP: Erenumab 70/140 mg QM
n=383 participants at risk
Participants received 70 mg erenumab QM from the beginning of the OLTP (week 12). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
|
CHU Substudy: Erenumab 140 mg PFS
n=42 participants at risk
Participants in the open-label treatment phase in the United States self-administered 140 mg erenumab via two 70 mg injections using a prefilled syringe (PFS) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
|
CHU Substudy: Erenumab 140 mg AI/Pen
n=41 participants at risk
Participants in the open-label treatment phase in the United States self-administered 140 mg erenumab via two 70 mg injections using an autoinjector/pen (AI)/pen) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
|
CHU Substudy: Total
n=83 participants at risk
Participants in the open-label treatment phase in the United States self-administered 140 mg erenumab via two 70 mg injections using a prefilled syringe or autoinjector/pen on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.8%
12/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
9.3%
10/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
5.7%
6/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
5.7%
6/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
21.4%
82/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
23.6%
59/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
29.0%
111/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
4.9%
2/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.4%
2/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.65%
1/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.95%
1/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.8%
3/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.3%
9/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
6.0%
15/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
6.3%
24/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.4%
1/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.2%
1/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
1.3%
2/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.8%
3/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.95%
1/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.8%
3/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
3.4%
13/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
7.2%
18/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
7.6%
29/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
General disorders
Fatigue
|
2.0%
3/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
4.6%
5/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.9%
2/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
3.8%
4/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
5.0%
19/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
4.4%
11/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
7.6%
29/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Infections and infestations
Bronchitis
|
0.65%
1/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.94%
1/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
4.4%
17/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
5.6%
14/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
8.1%
31/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Infections and infestations
Influenza
|
3.3%
5/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.93%
1/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
3.8%
4/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.94%
1/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
9.4%
36/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
12.4%
31/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
14.6%
56/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.4%
1/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.2%
1/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Infections and infestations
Pneumonia
|
0.65%
1/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.94%
1/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.9%
11/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
4.4%
11/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
5.7%
22/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Infections and infestations
Sinusitis
|
1.3%
2/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.9%
2/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.95%
1/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.9%
2/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
7.8%
30/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
10.4%
26/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
13.8%
53/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.4%
1/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.4%
1/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.4%
2/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
4/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.9%
2/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
3.8%
4/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.9%
2/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
7.8%
30/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
8.4%
21/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
12.5%
48/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.4%
1/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.2%
1/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
3/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.93%
1/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.9%
2/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.9%
2/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
13.6%
52/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
21.2%
53/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
20.4%
78/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
7.1%
3/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
4.9%
2/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
6.0%
5/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.65%
1/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.95%
1/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.94%
1/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
6.0%
23/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
9.2%
23/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
10.7%
41/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.4%
1/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.2%
1/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
5/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.93%
1/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.94%
1/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
6.8%
26/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
5.2%
13/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
9.7%
37/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.4%
1/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.2%
1/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.65%
1/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.93%
1/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.9%
2/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.9%
2/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
4.2%
16/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
4.4%
11/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
6.5%
25/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Nervous system disorders
Headache
|
0.65%
1/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
3.7%
4/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.95%
1/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.8%
3/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.6%
10/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
4.4%
11/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
5.5%
21/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.4%
1/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.2%
1/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
3/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.9%
2/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.95%
1/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
3.9%
15/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
5.6%
14/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
7.0%
27/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.65%
1/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.93%
1/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.9%
2/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.9%
2/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
3.9%
15/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.8%
7/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
5.2%
20/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
2.4%
1/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.2%
1/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
|
Vascular disorders
Hypertension
|
1.3%
2/153 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.93%
1/108 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/105 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
1.9%
2/106 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
3.7%
14/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
4.4%
11/250 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
6.5%
25/383 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/42 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/41 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
0.00%
0/83 • Double-blind Treatment Phase: From first dose of study drug in the DBTP until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase. Open-label Treatment Phase: From first dose in the OLTP up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks. CHU substudy: 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER