Trial Outcomes & Findings for A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis (MK-0822-004) (NCT NCT00112437)
NCT ID: NCT00112437
Last Updated: 2018-01-24
Results Overview
Percentage change in lumbar spine BMD (relative to baseline) at 12 Months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
399 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2018-01-24
Participant Flow
Approximately 375 participants were recruited from June 2005 to December 2005. Investigators used one or more of the following recruitment methods: Investigator Patient/Subject Database or Medical Records, Investigator's Local Recruitment/Advertising, Other Health Professional and, Physician Referral (Primary/Specialist/Family Doctor).
Participants entered screening followed by a 3-week placebo run-in. All took vitamin D3, 5600 IU once weekly, those with average daily calcium intakes \<1000 mg took calcium 500 mg/day as calcium carbonate. Participants were excluded from the active treatment based on predetermined exclusion criteria (Bone Mineral Density and laboratory results).
Participant milestones
| Measure |
Placebo-Base
One placebo tablet once a week
|
Odanacatib 3 Mg-Base
One odanacatib 3 mg tablet once a week
|
Odanacatib 10 Mg-Base
One odanacatib 10 mg tablet once a week
|
Odanacatib 25 Mg-Base
One odanacatib 25 mg tablet once a week
|
Odanacatib 50 Mg-Base
One odanacatib 50 mg tablet once a week
|
Placebo-Ext 1
One placebo tablet once a week
|
Odanacatib 3 Mg-Ext 1
One odanacatib 3 mg tablet once a week
|
Odanacatib 10 Mg-Ext 1
One odanacatib 10 mg tablet once a week
|
Odanacatib 25 Mg-Ext 1
One odanacatib 25 mg tablet once a week
|
Odanacatib 50 Mg-Ext 1
One odanacatib 50 mg tablet once a week
|
Placebo / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo Once Weekly-Ext 3
During this 24-month extension (Years 4-5), participants in this treatment group received one placebo tablet once a week.
|
Odanacatib 50 mg Once Weekly-Ext 3
During this 24-month extension (Years 4-5), participants in this treatment group received one odanacatib 50 mg tablet once a week.
|
Group A: Odanacatib 50 mg Once Weekly-Ext 4
During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet one a week. Group A consisted of a combination of participants who were treated with odanacatib 25 mg for 2 years,then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 50 mg for 10 years.
|
Group B: Odanacatib 50 mg Once Weekly-Ext 4
During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet one a week. Group B consisted of a combination participants who were treated with placebo for 2 years, then odanacatib 50 mg for 8 years; participants who were treated with odanacatib 3 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 10 mg for 2 years, then odanacatib 50 mg for 8 years.
|
Group C: Odanacatib 50 mg Once Weekly-Ext 4
During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet one a week. Group C consisted of a combination of participants who were treated with placebo for 3 years, then odanacatib 50 mg for 7 years; and participants who were treated with odanacatib 3 mg for 2 years, then placebo for 1 year, then odanacatib 50 mg for 7 years.
|
Group D: Odanacatib 50 mg Once Weekly-Ext 4
During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet once a week. Group D consists of a combination of participants who were treated with odanacatib 10 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; participants who were treated with odanacatib 25 mg for 5 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; and participants who were treated with odanacatib 50 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Year 1 (12-Month Base Study)
STARTED
|
83
|
82
|
77
|
79
|
78
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 1 (12-Month Base Study)
COMPLETED
|
68
|
64
|
65
|
71
|
66
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 1 (12-Month Base Study)
NOT COMPLETED
|
15
|
18
|
12
|
8
|
12
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 2 (12-Month Extension)
STARTED
|
0
|
0
|
0
|
0
|
0
|
63
|
62
|
63
|
69
|
63
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 2 (12-Month Extension)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
60
|
53
|
55
|
62
|
50
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 2 (12-Month Extension)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
3
|
9
|
8
|
7
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 3 (12-Month Extension)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
19
|
22
|
18
|
17
|
18
|
17
|
19
|
21
|
18
|
20
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 3 (12-Month Extension)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
17
|
17
|
18
|
16
|
17
|
13
|
16
|
20
|
16
|
19
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 3 (12-Month Extension)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
5
|
0
|
1
|
1
|
4
|
3
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Years 4-5 (24-Month Extension)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
41
|
100
|
0
|
0
|
0
|
0
|
|
Years 4-5 (24-Month Extension)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
37
|
92
|
0
|
0
|
0
|
0
|
|
Years 4-5 (24-Month Extension)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
8
|
0
|
0
|
0
|
0
|
|
Years 6-10 (60-Month Extension)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
28
|
34
|
23
|
32
|
|
Years 6-10 (60-Month Extension)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
23
|
22
|
22
|
27
|
|
Years 6-10 (60-Month Extension)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
12
|
1
|
5
|
Reasons for withdrawal
| Measure |
Placebo-Base
One placebo tablet once a week
|
Odanacatib 3 Mg-Base
One odanacatib 3 mg tablet once a week
|
Odanacatib 10 Mg-Base
One odanacatib 10 mg tablet once a week
|
Odanacatib 25 Mg-Base
One odanacatib 25 mg tablet once a week
|
Odanacatib 50 Mg-Base
One odanacatib 50 mg tablet once a week
|
Placebo-Ext 1
One placebo tablet once a week
|
Odanacatib 3 Mg-Ext 1
One odanacatib 3 mg tablet once a week
|
Odanacatib 10 Mg-Ext 1
One odanacatib 10 mg tablet once a week
|
Odanacatib 25 Mg-Ext 1
One odanacatib 25 mg tablet once a week
|
Odanacatib 50 Mg-Ext 1
One odanacatib 50 mg tablet once a week
|
Placebo / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo Once Weekly-Ext 3
During this 24-month extension (Years 4-5), participants in this treatment group received one placebo tablet once a week.
|
Odanacatib 50 mg Once Weekly-Ext 3
During this 24-month extension (Years 4-5), participants in this treatment group received one odanacatib 50 mg tablet once a week.
|
Group A: Odanacatib 50 mg Once Weekly-Ext 4
During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet one a week. Group A consisted of a combination of participants who were treated with odanacatib 25 mg for 2 years,then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 50 mg for 10 years.
|
Group B: Odanacatib 50 mg Once Weekly-Ext 4
During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet one a week. Group B consisted of a combination participants who were treated with placebo for 2 years, then odanacatib 50 mg for 8 years; participants who were treated with odanacatib 3 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 10 mg for 2 years, then odanacatib 50 mg for 8 years.
|
Group C: Odanacatib 50 mg Once Weekly-Ext 4
During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet one a week. Group C consisted of a combination of participants who were treated with placebo for 3 years, then odanacatib 50 mg for 7 years; and participants who were treated with odanacatib 3 mg for 2 years, then placebo for 1 year, then odanacatib 50 mg for 7 years.
|
Group D: Odanacatib 50 mg Once Weekly-Ext 4
During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet once a week. Group D consists of a combination of participants who were treated with odanacatib 10 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; participants who were treated with odanacatib 25 mg for 5 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; and participants who were treated with odanacatib 50 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Year 1 (12-Month Base Study)
Adverse Event
|
9
|
10
|
6
|
4
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 1 (12-Month Base Study)
Lack of Efficacy
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 1 (12-Month Base Study)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 1 (12-Month Base Study)
Protocol Violation
|
1
|
0
|
3
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 1 (12-Month Base Study)
Withdrawal by Subject
|
5
|
5
|
2
|
1
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 1 (12-Month Base Study)
moved
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 1 (12-Month Base Study)
patient was unsure that they needed drug
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 1 (12-Month Base Study)
DXA was lower by more than 8%
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 2 (12-Month Extension)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
6
|
1
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 2 (12-Month Extension)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
1
|
6
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 2 (12-Month Extension)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 2 (12-Month Extension)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 2 (12-Month Extension)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
4
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 2 (12-Month Extension)
Patient stopped taking medication
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 2 (12-Month Extension)
patient was out of windows
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 2 (12-Month Extension)
Moved
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 3 (12-Month Extension)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
3
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 3 (12-Month Extension)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 3 (12-Month Extension)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 3 (12-Month Extension)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 3 (12-Month Extension)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Year 3 (12-Month Extension)
cortisone therapy, upcoming surgery
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Years 4-5 (24-Month Extension)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Years 4-5 (24-Month Extension)
Discontinued for other reasons
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Years 4-5 (24-Month Extension)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Years 4-5 (24-Month Extension)
Participant moved
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Years 4-5 (24-Month Extension)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Years 6-10 (60-Month Extension)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
1
|
|
Years 6-10 (60-Month Extension)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Years 6-10 (60-Month Extension)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Years 6-10 (60-Month Extension)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Years 6-10 (60-Month Extension)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Years 6-10 (60-Month Extension)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
6
|
0
|
3
|
Baseline Characteristics
A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis (MK-0822-004)
Baseline characteristics by cohort
| Measure |
Placebo-Base
n=83 Participants
One placebo tablet once a week
|
Odanacatib 3 Mg-Base
n=82 Participants
One odanacatib 3 mg tablet once a week
|
Odanacatib 10 Mg-Base
n=77 Participants
One odanacatib 10 mg tablet once a week
|
Odanacatib 25 Mg-Base
n=79 Participants
One odanacatib 25 mg tablet once a week
|
Odanacatib 50 Mg-Base
n=78 Participants
One odanacatib 50 mg tablet once a week
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
64.5 years
STANDARD_DEVIATION 8.1 • n=21 Participants
|
64.2 years
STANDARD_DEVIATION 7.8 • n=10 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
399 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: Analysis at Month 12 used Full-Analysis-Set Population of participants who took at least one dose of study medication and had necessary follow-up information, in their randomization treatment group, with last observation data carried forward. Seven patients had a baseline value, but no value at Month 12 for lumbar spine Bone Mineral Density.
Percentage change in lumbar spine BMD (relative to baseline) at 12 Months.
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=77 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=79 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=78 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=77 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=81 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
|
1.50 Percentage change
Interval 0.82 to 2.19
|
-0.62 Percentage change
Interval -1.3 to 0.05
|
2.65 Percentage change
Interval 1.97 to 3.33
|
3.37 Percentage change
Interval 2.68 to 4.05
|
—
|
—
|
—
|
—
|
—
|
-0.13 Percentage change
Interval -0.8 to 0.54
|
PRIMARY outcome
Timeframe: Baseline and 24 monthsPopulation: Analysis on lumbar spine BMD (g/cm2) at Month 24 used the Full-Analysis-Set Population with Last Observation Carried Forward from Month 18 to 24. No data were carried forward from the core to the extension period. Only patients who took at least one dose of extension medication were included. 17 patients were excluded from FAS.
Percentage change in lumbar spine BMD (relative to baseline) at 24 Months.
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=60 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=58 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=65 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=58 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=62 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Lumbar Spine BMD at 24 Months
|
3.20 Percentage Change
Interval 2.25 to 4.15
|
-1.03 Percentage Change
Interval -2.0 to -0.07
|
4.26 Percentage Change
Interval 3.35 to 5.18
|
5.48 Percentage Change
Interval 4.52 to 6.44
|
—
|
—
|
—
|
—
|
—
|
-0.19 Percentage Change
Interval -1.13 to 0.75
|
PRIMARY outcome
Timeframe: Baseline and 36 monthsPopulation: This analysis was performed at Month 36 using the Per-protocol approach which includes patients who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.
Percentage change in lumbar spine BMD (relative to baseline) at 36 months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=17 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=16 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=13 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=12 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
n=10 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
n=12 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
n=18 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
n=15 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
n=17 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Lumbar Spine BMD at 36 Months
|
-1.57 Percent Change
Interval -3.67 to 0.54
|
2.95 Percent Change
Interval 0.79 to 5.11
|
4.41 Percent Change
Interval 2.01 to 6.82
|
2.03 Percent Change
Interval -0.47 to 4.53
|
6.11 Percent Change
Interval 3.37 to 8.85
|
0.32 Percent Change
Interval -2.18 to 2.82
|
7.45 Percent Change
Interval 5.41 to 9.48
|
1.39 Percent Change
Interval -0.84 to 3.63
|
7.85 Percent Change
Interval 5.74 to 9.95
|
0.42 Percent Change
Interval -1.89 to 2.73
|
PRIMARY outcome
Timeframe: Baseline and Month 60Population: All participants who took at least one dose of base study medication and at least one dose of extension medication. Missing values were imputed using last observation-carried-forward principle.
Percentage change from baseline in lumbar spine BMD at 60 months.
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=13 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Lumbar Spine BMD at 60 Months
|
—
|
11.88 Percentage change
Interval 7.23 to 16.54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.41 Percentage change
Interval -3.1 to 2.28
|
PRIMARY outcome
Timeframe: Baseline and Month 120Population: This analysis was based on the FAS population, which included all randomized participants who took at least 1 dose of extension study drug and had the necessary extension data available for this endpoint. Missing data were not imputed.
Percentage change from baseline in lumbar spine BMD at 120 Months.
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=17 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=16 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=21 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=20 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Lumbar Spine BMD at 120 Months
|
17.18 Percentage Change
Interval 11.48 to 22.88
|
14.56 Percentage Change
Interval 11.1 to 18.02
|
7.71 Percentage Change
Interval 4.46 to 10.95
|
—
|
—
|
—
|
—
|
—
|
—
|
16.92 Percentage Change
Interval 12.28 to 21.55
|
PRIMARY outcome
Timeframe: Years 6-10 (up to 60 months, up to 14 days after the last dose of study drug)Population: All participants who received at least 1 administration of the trial drug during treatment years 6-10
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=23 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=34 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=32 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=28 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment Years 6-10 (60 Months)
|
23 Participants
|
34 Participants
|
32 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
27 Participants
|
PRIMARY outcome
Timeframe: Years 6-10 (up to 60 months)Population: All participants who received at least 1 administration of the trial drug during treatment years 6-10.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=23 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=34 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=32 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=28 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Years 6-10 (60 Months)
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: This analysis was performed at Month 12 using Full-Analysis-Set approach with Last Observation Carried Forward.
Percentage change in total hip BMD (relative to baseline) at 12 months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=77 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=79 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=78 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=77 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=81 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Total Hip BMD at 12 Months
|
1.05 Percentage Change
Interval 0.44 to 1.67
|
-1.36 Percentage Change
Interval -1.97 to -0.75
|
1.45 Percentage Change
Interval 0.84 to 2.07
|
1.87 Percentage Change
Interval 1.25 to 2.49
|
—
|
—
|
—
|
—
|
—
|
-0.61 Percentage Change
Interval -1.22 to -0.01
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: This analysis was performed at Month 12 using Full-Analysis-Set approach with Last Observation Carried Forward.
Percentage change in femoral neck BMD (relative to baseline) at 12 months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=77 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=79 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=78 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=77 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=81 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Femoral Neck BMD at 12 Months
|
0.74 Percentage change
Interval 0.05 to 1.42
|
-0.32 Percentage change
Interval -0.99 to 0.35
|
1.76 Percentage change
Interval 1.08 to 2.44
|
2.53 Percentage change
Interval 1.85 to 3.21
|
—
|
—
|
—
|
—
|
—
|
-0.13 Percentage change
Interval -0.79 to 0.54
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: This analysis was performed at Month 12 using Full-Analysis-Set approach with Last Observation Carried Forward.
Percentage change in trochanter BMD (relative to baseline) at 12 months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=77 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=79 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=78 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=77 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=81 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Trochanter BMD at 12 Months
|
1.65 Percentage change
Interval 0.72 to 2.58
|
-1.02 Percentage change
Interval -1.94 to -0.1
|
1.91 Percentage change
Interval 0.99 to 2.84
|
2.21 Percentage change
Interval 1.28 to 3.14
|
—
|
—
|
—
|
—
|
—
|
-0.73 Percentage change
Interval -1.64 to 0.18
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: This analysis was performed at Month 12 using Full-Analysis-Set Population with Last Observation Carried Forward.
Percentage change in total body BMD (relative to baseline) at 12 months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=70 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=71 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=75 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=70 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=72 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Total Body BMD at 12 Months
|
-1.06 Percentage change
Interval -1.81 to -0.3
|
-1.89 Percentage change
Interval -2.64 to -1.14
|
-0.51 Percentage change
Interval -1.23 to 0.22
|
-0.13 Percentage change
Interval -0.89 to 0.62
|
—
|
—
|
—
|
—
|
—
|
-0.42 Percentage change
Interval -1.16 to 0.32
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: This analysis was performed at Month 12 using Full-Analysis-Set Population with Last Observation Carried Forward
Percentage change in distal forearm BMD (relative to baseline) at 12 months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=77 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=79 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=78 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=77 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=81 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Distal Forearm BMD at 12 Months
|
-1.00 Percentage change
Interval -1.73 to -0.28
|
-2.55 Percentage change
Interval -3.26 to -1.83
|
-0.17 Percentage change
Interval -0.89 to 0.55
|
-0.04 Percentage change
Interval -0.77 to 0.68
|
—
|
—
|
—
|
—
|
—
|
-1.27 Percentage change
Interval -1.98 to -0.57
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.
Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary N-telopeptides of Type I collagen (u-NTx)) at 12 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=56 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=57 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=63 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=56 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=62 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 12 Months
|
-34.21 Percentage change
Interval -42.94 to -24.15
|
8.80 Percentage change
Interval -5.5 to 25.27
|
-48.29 Percentage change
Interval -54.8 to -40.84
|
-60.23 Percentage change
Interval -65.51 to -54.13
|
—
|
—
|
—
|
—
|
—
|
-2.37 Percentage change
Interval -14.78 to 11.85
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: This analysis was a geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) at 12 Months.
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=56 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=57 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=62 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=55 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=62 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 12 Months
|
-22.24 Percentage change
Interval -35.45 to -6.32
|
19.12 Percentage change
Interval -0.94 to 43.24
|
-36.15 Percentage change
Interval -46.54 to -23.75
|
-56.91 Percentage change
Interval -64.31 to -47.99
|
—
|
—
|
—
|
—
|
—
|
-0.58 Percentage change
Interval -16.79 to 18.78
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: This analysis was a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.
Back-transformation (geometric mean) of the Least Squares Mean of the log-values percentage change from baseline in biochemical marker of bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 12 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=55 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=57 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=63 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=55 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=60 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 12 Months
|
-8.58 Percentage change
Interval -21.33 to 6.24
|
20.91 Percentage change
Interval 4.33 to 40.12
|
-8.50 Percentage change
Interval -20.52 to 5.33
|
-25.52 Percentage change
Interval -35.93 to -13.43
|
—
|
—
|
—
|
—
|
—
|
-7.25 Percentage change
Interval -19.73 to 7.18
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: This analysis was a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)), at 12 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=57 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=58 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=64 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=58 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=62 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 12 Months
|
8.95 Percentage change
Interval 0.1 to 18.6
|
42.08 Percentage change
Interval 30.64 to 54.52
|
2.66 Percentage change
Interval -5.25 to 11.24
|
-18.35 Percentage change
Interval -24.93 to -11.18
|
—
|
—
|
—
|
—
|
—
|
-2.77 Percentage change
Interval -10.39 to 5.49
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: This analysis was a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change in Biochemical Marker of Bone turnover (serum N-terminal propeptide of Type 1 collagen (s-P1NP) (relative to baseline) at 12 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=57 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=57 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=63 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=58 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=62 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 12 Months
|
2.33 Percentage change
Interval -10.63 to 17.16
|
50.81 Percentage change
Interval 31.69 to 72.7
|
2.23 Percentage change
Interval -10.12 to 16.28
|
-31.83 Percentage change
Interval -40.4 to -22.02
|
—
|
—
|
—
|
—
|
—
|
3.91 Percentage change
Interval -8.79 to 18.38
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.
Percentage change in total hip Bone Mineral Density (relative to baseline) at 24 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=59 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=57 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=65 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=58 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=61 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Total Hip Bone Mineral Density at 24 Months
|
1.82 Percentage change
Interval 0.88 to 2.76
|
-1.44 Percentage change
Interval -2.4 to -0.48
|
2.55 Percentage change
Interval 1.66 to 3.44
|
3.16 Percentage change
Interval 2.22 to 4.11
|
—
|
—
|
—
|
—
|
—
|
-0.93 Percentage change
Interval -1.86 to -0.01
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.
Percentage change in femoral neck Bone Mineral Density (relative to baseline) at 24 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=59 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=57 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=65 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=58 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=61 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Femoral Neck BMD at 24 Months
|
1.97 Percentage change
Interval 0.95 to 2.98
|
-1.25 Percentage change
Interval -2.29 to -0.22
|
2.73 Percentage change
Interval 1.76 to 3.69
|
3.84 Percentage change
Interval 2.82 to 4.86
|
—
|
—
|
—
|
—
|
—
|
-0.85 Percentage change
Interval -1.85 to 0.16
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.
Percentage change from baseline in trochanter BMD (relative to baseline) at 24 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=59 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=57 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=65 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=58 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=61 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Trochanter BMD at 24 Months
|
3.61 Percentage Change
Interval 2.26 to 4.97
|
-0.85 Percentage Change
Interval -2.23 to 0.53
|
3.75 Percentage Change
Interval 2.46 to 5.04
|
4.28 Percentage Change
Interval 2.92 to 5.65
|
—
|
—
|
—
|
—
|
—
|
-0.81 Percentage Change
Interval -2.15 to 0.53
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward. No data was carried forward from the core to the extension period.
Percentage change in total body BMD (relative to baseline) at 24 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=48 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=47 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=58 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=51 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=56 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Total Body BMD at 24 Months
|
-1.35 Percentage change
Interval -2.29 to -0.4
|
-2.70 Percentage change
Interval -3.66 to -1.74
|
-0.43 Percentage change
Interval -1.29 to 0.43
|
0.19 Percentage change
Interval -0.73 to 1.11
|
—
|
—
|
—
|
—
|
—
|
-1.54 Percentage change
Interval -2.42 to -0.66
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.
Percentage change in distal forearm BMD (relative to baseline) at 24 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=60 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=58 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=65 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=57 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=61 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Distal Forearm BMD at 24 Months
|
-1.22 Percentage change
Interval -2.31 to -0.13
|
-5.70 Percentage change
Interval -6.8 to -4.59
|
-0.65 Percentage change
Interval -1.7 to 0.39
|
0.15 Percentage change
Interval -0.97 to 1.27
|
—
|
—
|
—
|
—
|
—
|
-2.75 Percentage change
Interval -3.83 to -1.66
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: Analysis used a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Back-transformation (geometric mean) of the Least Squares Mean of the log-values percentage change from baseline in biochemical marker of bone turnover (u-NTx) (relative to baseline) at 24 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=41 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=45 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=51 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=38 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=56 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 24 Months
|
-40.57 Percentage change
Interval -50.32 to -28.9
|
12.89 Percentage change
Interval -4.93 to 34.05
|
-38.30 Percentage change
Interval -47.48 to -27.51
|
-51.83 Percentage change
Interval -60.05 to -41.91
|
—
|
—
|
—
|
—
|
—
|
-4.62 Percentage change
Interval -18.23 to 11.25
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.
Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) (relative to baseline) at 24 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=42 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=45 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=52 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=39 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=56 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 24 Months
|
8.79 Percentage change
Interval -9.35 to 30.57
|
54.94 Percentage change
Interval 29.83 to 84.92
|
-6.52 Percentage change
Interval -20.7 to 10.19
|
-30.57 Percentage change
Interval -42.6 to -16.2
|
—
|
—
|
—
|
—
|
—
|
32.77 Percentage change
Interval 13.28 to 55.61
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 24 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=40 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=45 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=51 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=38 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=56 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 24 Months
|
-7.57 Geometric LS Mean percent change
Interval -22.03 to 9.57
|
15.96 Geometric LS Mean percent change
Interval -1.29 to 36.23
|
-14.30 Geometric LS Mean percent change
Interval -26.3 to -0.33
|
-22.49 Geometric LS Mean percent change
Interval -34.96 to -7.64
|
—
|
—
|
—
|
—
|
—
|
-5.78 Geometric LS Mean percent change
Interval -18.44 to 8.84
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)) (relative to baseline) at 24 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=42 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=47 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=53 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=42 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=57 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 24 Months
|
2.99 Geometric LS Mean percent change
Interval -6.57 to 13.54
|
40.17 Geometric LS Mean percent change
Interval 27.8 to 53.73
|
10.62 Geometric LS Mean percent change
Interval 1.4 to 20.69
|
-13.62 Geometric LS Mean percent change
Interval -21.36 to -4.32
|
—
|
—
|
—
|
—
|
—
|
3.38 Geometric LS Mean percent change
Interval -4.94 to 12.44
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Back-transformation (geometric mean) of the least squares mean of the log-values percentage change from baseline in biochemical marker of bone turnover (s-P1NP) (relative to baseline) at 24 months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=42 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=47 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=53 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=42 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=57 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 24 Months
|
9.07 Geometric LS Mean percent change
Interval -6.28 to 26.93
|
50.52 Geometric LS Mean percent change
Interval 30.37 to 73.79
|
14.60 Geometric LS Mean percent change
Interval 0.08 to 31.23
|
-20.20 Geometric LS Mean percent change
Interval -31.49 to -7.05
|
—
|
—
|
—
|
—
|
—
|
1.29 Geometric LS Mean percent change
Interval -11.11 to 15.43
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: This analysis was performed at Month 36 using the Per-Protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.
Percentage change in total hip BMD (relative to baseline) at 36 months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=17 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=16 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=12 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=11 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
n=9 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
n=12 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
n=19 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
n=15 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
n=17 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Total Hip BMD at 36 Months
|
-0.63 Percentage change
Interval -2.59 to 1.33
|
1.16 Percentage change
Interval -0.86 to 3.17
|
2.75 Percentage change
Interval 0.42 to 5.07
|
0.96 Percentage change
Interval -1.48 to 3.39
|
4.61 Percentage change
Interval 1.93 to 7.3
|
1.64 Percentage change
Interval -0.69 to 3.97
|
5.70 Percentage change
Interval 3.85 to 7.54
|
-0.48 Percentage change
Interval -2.56 to 1.6
|
5.83 Percentage change
Interval 3.87 to 7.79
|
-0.77 Percentage change
Interval -2.92 to 1.38
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: This analysis was performed at Month 36 using the Per-Protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.
Percentage change in femoral neck BMD (relative to baseline) at 36 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=17 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=16 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=12 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=11 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
n=9 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
n=12 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
n=19 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
n=15 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
n=17 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Femoral Neck BMD at 36 Months
|
-1.04 Percentage change
Interval -2.99 to 0.92
|
1.03 Percentage change
Interval -0.98 to 3.04
|
2.26 Percentage change
Interval -0.06 to 4.59
|
-0.14 Percentage change
Interval -2.57 to 2.3
|
5.06 Percentage change
Interval 2.38 to 7.74
|
0.80 Percentage change
Interval -1.52 to 3.13
|
7.23 Percentage change
Interval 5.38 to 9.07
|
2.26 Percentage change
Interval 0.19 to 4.34
|
4.97 Percentage change
Interval 3.01 to 6.93
|
-0.52 Percentage change
Interval -2.67 to 1.63
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: This analysis was performed at Month 36 using the Per-Protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.
Percentage change in trochanter BMD (relative to baseline) at 36 months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=17 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=16 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=12 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=11 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
n=9 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
n=12 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
n=19 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
n=15 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
n=17 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Trochanter BMD at 36 Months
|
-1.04 Percentage Change
Interval -4.0 to 1.92
|
2.32 Percentage Change
Interval -0.72 to 5.36
|
4.53 Percentage Change
Interval 1.01 to 8.04
|
0.66 Percentage Change
Interval -3.02 to 4.34
|
8.21 Percentage Change
Interval 4.16 to 12.27
|
1.14 Percentage Change
Interval -2.38 to 4.65
|
7.97 Percentage Change
Interval 5.18 to 10.76
|
-0.69 Percentage Change
Interval -3.83 to 2.46
|
7.44 Percentage Change
Interval 4.48 to 10.41
|
-0.46 Percentage Change
Interval -3.71 to 2.79
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: This analysis was performed at Month 36 using the Per-Protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.
Percentage change from baseline in total body BMD (relative to baseline) at 36 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=16 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=13 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=12 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
n=9 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
n=12 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
n=18 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
n=15 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
n=17 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Total Body BMD at 36 Months
|
-3.63 Percentage change
Interval -5.74 to -1.52
|
-2.20 Percentage change
Interval -4.45 to 0.05
|
0.28 Percentage change
Interval -2.07 to 2.62
|
-2.28 Percentage change
Interval -4.71 to 0.15
|
-1.22 Percentage change
Interval -4.03 to 1.58
|
-0.85 Percentage change
Interval -3.29 to 1.58
|
0.56 Percentage change
Interval -1.43 to 2.54
|
-1.84 Percentage change
Interval -4.02 to 0.34
|
-0.38 Percentage change
Interval -2.43 to 1.67
|
0.13 Percentage change
Interval -2.12 to 2.38
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: This analysis was performed at Month 36 using the Per-protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.
Percentage change in distal forearm BMD (relative to baseline) at 36 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=16 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=15 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=13 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=12 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
n=10 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
n=12 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
n=18 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
n=17 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Distal Forearm BMD at 36 Months
|
-6.59 Percentage Change
Interval -8.95 to -4.23
|
-4.04 Percentage Change
Interval -6.47 to -1.61
|
-6.34 Percentage Change
Interval -8.96 to -3.73
|
-1.74 Percentage Change
Interval -4.46 to 0.97
|
-3.74 Percentage Change
Interval -6.71 to -0.76
|
-2.39 Percentage Change
Interval -5.11 to 0.32
|
0.53 Percentage Change
Interval -1.69 to 2.74
|
-2.73 Percentage Change
Interval -5.25 to -0.22
|
-0.26 Percentage Change
Interval -2.55 to 2.03
|
-2.08 Percentage Change
Interval -4.6 to 0.43
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Percentage change from baseline in biochemical marker of bone turnover (u-NTx) at 36 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=13 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=15 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=16 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=13 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
n=11 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
n=10 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
n=18 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
n=17 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 36 Months
|
-11.90 Percentage change
Interval -35.76 to 20.83
|
-55.12 Percentage change
Interval -66.51 to 39.85
|
-57.17 Percentage change
Interval -67.75 to -43.12
|
-12.15 Percentage change
Interval -35.91 to 20.43
|
-49.10 Percentage change
Interval -63.88 to -28.27
|
14.26 Percentage change
Interval -20.17 to 63.53
|
-52.11 Percentage change
Interval -63.33 to -37.45
|
27.55 Percentage change
Interval -5.86 to 72.8
|
-50.51 Percentage change
Interval -62.44 to -34.81
|
-17.43 Percentage change
Interval -39.06 to 11.86
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Percentage change from baseline in biochemical marker of bone turnover (s-CTx) at 36 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=13 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=15 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=16 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=13 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
n=11 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
n=9 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
n=18 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
n=17 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 36 Months
|
-4.69 Percentage change
Interval -33.13 to 35.85
|
-41.30 Percentage change
Interval -57.74 to -18.47
|
-44.62 Percentage change
Interval -59.72 to -23.88
|
18.24 Percentage change
Interval -16.98 to 68.41
|
-26.26 Percentage change
Interval -49.81 to 8.33
|
61.14 Percentage change
Interval 5.5 to 146.12
|
-36.71 Percentage change
Interval -53.09 to -14.6
|
10.32 Percentage change
Interval -21.52 to 55.1
|
-23.93 Percentage change
Interval -44.15 to 3.63
|
-0.09 Percentage change
Interval -28.93 to 40.46
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Percentage change from baseline in biochemical marker of bone turnover u-DPyr at 36 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=13 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=15 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=13 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
n=11 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
n=10 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
n=18 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
n=17 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 36 Months
|
-7.82 Percentage change
Interval -34.76 to 30.26
|
-14.95 Percentage change
Interval -38.27 to 17.18
|
-26.27 Percentage change
Interval -47.1 to 2.76
|
-4.69 Percentage change
Interval -32.51 to 34.6
|
0.43 Percentage change
Interval -31.0 to 46.19
|
-9.16 Percentage change
Interval -38.64 to 34.48
|
-16.41 Percentage change
Interval -37.59 to 11.97
|
22.41 Percentage change
Interval -12.2 to 70.66
|
-16.84 Percentage change
Interval -38.49 to 12.45
|
-18.69 Percentage change
Interval -41.68 to 13.36
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.
Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase \[s-BSAP\]) at 36 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=16 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=16 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=13 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
n=11 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
n=12 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
n=18 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
n=17 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 36 Months
|
14.26 Geometric Mean Percent Change
Interval -1.77 to 32.91
|
10.86 Geometric Mean Percent Change
Interval -3.69 to 27.62
|
9.13 Geometric Mean Percent Change
Interval -5.2 to 25.62
|
12.95 Geometric Mean Percent Change
Interval -3.41 to 32.08
|
8.49 Geometric Mean Percent Change
Interval -8.48 to 28.62
|
33.74 Geometric Mean Percent Change
Interval 13.71 to 57.31
|
11.12 Geometric Mean Percent Change
Interval -2.67 to 26.86
|
1.30 Geometric Mean Percent Change
Interval -12.85 to 17.76
|
17.90 Geometric Mean Percent Change
Interval 2.83 to 35.17
|
7.73 Geometric Mean Percent Change
Interval -7.32 to 25.24
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Percentage change from baseline in biochemical marker of bone turnover (serum N-terminal propeptide of Type 1 collagen \[s-P1NP\]) at 36 months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=16 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=15 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=13 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
n=11 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
n=12 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
n=18 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
n=17 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen [s-P1NP]) at 36 Months
|
-13.11 Percentage change
Interval -34.35 to 15.0
|
-18.79 Percentage change
Interval -37.44 to 5.42
|
-21.08 Percentage change
Interval -39.75 to 3.37
|
8.58 Percentage change
Interval -18.75 to 45.11
|
12.44 Percentage change
Interval -17.98 to 54.13
|
22.57 Percentage change
Interval -9.27 to 65.59
|
-8.14 Percentage change
Interval -28.14 to 17.42
|
-0.77 Percentage change
Interval -24.94 to 31.18
|
-6.20 Percentage change
Interval -27.2 to 20.86
|
-20.79 Percentage change
Interval -40.08 to 4.72
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Percentage change from baseline in biochemical marker of bone turnover (serum bone tartrate-resistant acid phosphatase isoform 5b \[TRAP 5-b\]) at 36 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=10 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=11 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=12 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=10 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
n=9 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
n=10 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
n=15 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
n=10 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
n=15 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=10 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b [TRAP 5-b]) at 36 Months
|
33.25 Percentage change
Interval 13.12 to 56.97
|
52.37 Percentage change
Interval 30.34 to 78.12
|
59.37 Percentage change
Interval 37.24 to 85.08
|
56.71 Percentage change
Interval 33.04 to 84.6
|
82.94 Percentage change
Interval 53.93 to 117.42
|
56.42 Percentage change
Interval 32.79 to 84.26
|
77.90 Percentage change
Interval 55.63 to 103.36
|
47.61 Percentage change
Interval 25.3 to 73.88
|
96.70 Percentage change
Interval 72.08 to 124.85
|
52.98 Percentage change
Interval 29.87 to 80.21
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsPopulation: This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Percentage change from baseline in biochemical marker of bone turnover (serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen \[1-CTP\]) at 36 Months
Outcome measures
| Measure |
Odanacatib 3 mg / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Odanacatib 50 Mg-Ext 2
n=13 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
n=16 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Placebo-Ext 2
n=12 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
n=11 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / 50 Mg-Ext 2
n=11 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
n=19 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Placebo-Ext 2
n=15 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
n=18 Participants
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Placebo / Placebo-Ext 2
n=14 Participants
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months
|
1.67 Percentage change
Interval -21.41 to 31.53
|
193.91 Percentage change
Interval 125.61 to 282.89
|
187.37 Percentage change
Interval 126.25 to 264.99
|
58.76 Percentage change
Interval 20.27 to 109.56
|
188.50 Percentage change
Interval 116.34 to 284.74
|
77.94 Percentage change
Interval 33.46 to 137.24
|
231.93 Percentage change
Interval 166.74 to 313.05
|
27.20 Percentage change
Interval -0.61 to 62.79
|
236.64 Percentage change
Interval 168.69 to 321.76
|
7.40 Percentage change
Interval -16.78 to 38.6
|
Adverse Events
Years 1-2 Placebo/Placebo-Ext 1
Serious events: 8 serious events
Other events: 68 other events
Deaths: 0 deaths
Years 1-2 Odanacatib 3 mg/Odanacatib 3 Mg-Ext 1
Serious events: 12 serious events
Other events: 66 other events
Deaths: 0 deaths
Years 1-2 Odanacatib 10 mg/Odanacatib 10 Mg-Ext 1
Serious events: 10 serious events
Other events: 67 other events
Deaths: 0 deaths
Years 1-2 Odanacatib 25 mg/Odanacatib 25 Mg-Ext 1
Serious events: 9 serious events
Other events: 67 other events
Deaths: 0 deaths
Years 1-2 Odanacatib 50 mg/Odanacatib 50 Mg-Ext 1
Serious events: 14 serious events
Other events: 66 other events
Deaths: 0 deaths
Year 3 Placebo/Placebo-Ext 2
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Year 3 Placebo/Odanacatib 50 Mg-Ext 2
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Year 3 Odanacatib 3 mg/Placebo-Ext 2
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Year 3 Odanacatib 3 mg/Odanacatib 50 Mg-Ext 2
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Year 3 Odanacatib 10 mg/Placebo-Ext 2
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Year 3 Odanacatib 10 mg/Odanacatib 50 Mg-Ext 2
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Year 3 Odanacatib 25 mg/Placebo-Ext 2
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Year 3 Odanacatib 25 mg/Odanacatib 50 Mg-Ext 2
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Year 3 Odanacatib 50 mg/Placebo-Ext 2
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Year 3 Odanacatib 50 mg/Odanacatib 50 Mg-Ext 2
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Years 4-5 Combined Group A.1: Odanacatib 50 mg
Serious events: 16 serious events
Other events: 64 other events
Deaths: 0 deaths
Years 4-5 Combined Group A.2: Odanacatib 50 mg
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Years 4-5 Combined Group A.3: Placebo
Serious events: 8 serious events
Other events: 33 other events
Deaths: 0 deaths
Years 6-10 Group A: Odanacatib 50 mg Once Weekly
Serious events: 8 serious events
Other events: 25 other events
Deaths: 0 deaths
Years 6-10 Group B: Odanacatib 50 mg Once Weekly
Serious events: 14 serious events
Other events: 31 other events
Deaths: 0 deaths
Years 6-10 Group C: Odanacatib 50 mg Once Weekly
Serious events: 6 serious events
Other events: 23 other events
Deaths: 0 deaths
Years 6-10 Group D: Odanacatib 50 mg Once Weekly
Serious events: 12 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Years 1-2 Placebo/Placebo-Ext 1
n=83 participants at risk
One placebo tablet once a week
|
Years 1-2 Odanacatib 3 mg/Odanacatib 3 Mg-Ext 1
n=82 participants at risk
One odanacatib 3 mg tablet once a week
|
Years 1-2 Odanacatib 10 mg/Odanacatib 10 Mg-Ext 1
n=77 participants at risk
One odanacatib 10 mg tablet once a week
|
Years 1-2 Odanacatib 25 mg/Odanacatib 25 Mg-Ext 1
n=79 participants at risk
One odanacatib 25 mg tablet once a week
|
Years 1-2 Odanacatib 50 mg/Odanacatib 50 Mg-Ext 1
n=78 participants at risk
One odanacatib 50 mg tablet once a week
|
Year 3 Placebo/Placebo-Ext 2
n=19 participants at risk
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Year 3 Placebo/Odanacatib 50 Mg-Ext 2
n=22 participants at risk
During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Year 3 Odanacatib 3 mg/Placebo-Ext 2
n=18 participants at risk
During this 12-month extension (Year 3), participants took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Year 3 Odanacatib 3 mg/Odanacatib 50 Mg-Ext 2
n=17 participants at risk
During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Year 3 Odanacatib 10 mg/Placebo-Ext 2
n=18 participants at risk
During this 12-month extension (Year 3), participants took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Year 3 Odanacatib 10 mg/Odanacatib 50 Mg-Ext 2
n=17 participants at risk
During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Year 3 Odanacatib 25 mg/Placebo-Ext 2
n=19 participants at risk
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Year 3 Odanacatib 25 mg/Odanacatib 50 Mg-Ext 2
n=21 participants at risk
During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Year 3 Odanacatib 50 mg/Placebo-Ext 2
n=18 participants at risk
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Year 3 Odanacatib 50 mg/Odanacatib 50 Mg-Ext 2
n=20 participants at risk
During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Years 4-5 Combined Group A.1: Odanacatib 50 mg
n=73 participants at risk
Combined Group A.1 consists of participants who received odanacatib 50 mg once a week during Year 3.
During this 24-month extension (Years 4-5), these participants continued to receive odanacatib 50 mg once a week.
|
Years 4-5 Combined Group A.2: Odanacatib 50 mg
n=27 participants at risk
Combined Group A.2 consists of participants who received placebo or odanacatib 3 mg in Years 1, 2 and 3. During this 24-month extension (Years 4-5), these participants received odanacatib 50 mg once a week.
|
Years 4-5 Combined Group A.3: Placebo
n=41 participants at risk
Combined Group A.3 consists of participants who, during this 24-month extension (Years 4-5), received placebo once a week.
|
Years 6-10 Group A: Odanacatib 50 mg Once Weekly
n=28 participants at risk
Group A consists of a combination of participants who were treated with odanacatib 25 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 50 mg for 10 years.
|
Years 6-10 Group B: Odanacatib 50 mg Once Weekly
n=34 participants at risk
Group B consists of a combination participants who were treated with placebo for 2 years, then odanacatib 50 mg for 8 years; participants who were treated with odanacatib 3 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 10 mg for 2 years, then odanacatib 50 mg for 8 years.
|
Years 6-10 Group C: Odanacatib 50 mg Once Weekly
n=23 participants at risk
Group C consists of a combination of participants who were treated with placebo for 3 years, then odanacatib 50 mg for 7 years; and participants who were treated with odanacatib 3 mg for 2 years, then placebo for 1 year, then odanacatib 50 mg for 7 years
|
Years 6-10 Group D: Odanacatib 50 mg Once Weekly
n=32 participants at risk
Group D consists of a combination of participants who were treated with odanacatib 10 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; participants who were treated with odanacatib 25 mg for 5 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; and participants who were treated with odanacatib 50 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Bronchitis
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Cardiac disorders
Arteriospasm Coronary
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Endocrine disorders
Hypoparathyroidism secondary
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Eye disorders
Macular Hole
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Eye disorders
Retinal Detachment
|
1.2%
1/83 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Anal Fistula
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Peritonitis
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
General disorders
Chest Pain
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Diverticulitis
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Pneumonia Streptococcal
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Post Procedural Bile Leak
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Investigations
Electrocardiogram ST-T Change
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Investigations
Weight Decreased
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.5%
4/73 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic Fracture
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal Cancer
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.3%
3/41 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.1%
2/28 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer In Situ
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Thyroid Cancer
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Reversible Ischaemic Neurological Deficit
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Reproductive system and breast disorders
Genital Prolapse
|
2.4%
2/83 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
2/34 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Eye disorders
Cataract
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Trigger Finger
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Metastatic
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Neoplasm
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
VIIth Nerve Paralysis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Anal Sphincter Atony
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurilemmoma Benign
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema Nodosum
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Incarcerated incisional hernia
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Reproductive system and breast disorders
Ovarian cyst torsion
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Vascular disorders
Hypotension
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
Other adverse events
| Measure |
Years 1-2 Placebo/Placebo-Ext 1
n=83 participants at risk
One placebo tablet once a week
|
Years 1-2 Odanacatib 3 mg/Odanacatib 3 Mg-Ext 1
n=82 participants at risk
One odanacatib 3 mg tablet once a week
|
Years 1-2 Odanacatib 10 mg/Odanacatib 10 Mg-Ext 1
n=77 participants at risk
One odanacatib 10 mg tablet once a week
|
Years 1-2 Odanacatib 25 mg/Odanacatib 25 Mg-Ext 1
n=79 participants at risk
One odanacatib 25 mg tablet once a week
|
Years 1-2 Odanacatib 50 mg/Odanacatib 50 Mg-Ext 1
n=78 participants at risk
One odanacatib 50 mg tablet once a week
|
Year 3 Placebo/Placebo-Ext 2
n=19 participants at risk
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Year 3 Placebo/Odanacatib 50 Mg-Ext 2
n=22 participants at risk
During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
|
Year 3 Odanacatib 3 mg/Placebo-Ext 2
n=18 participants at risk
During this 12-month extension (Year 3), participants took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Year 3 Odanacatib 3 mg/Odanacatib 50 Mg-Ext 2
n=17 participants at risk
During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
|
Year 3 Odanacatib 10 mg/Placebo-Ext 2
n=18 participants at risk
During this 12-month extension (Year 3), participants took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
|
Year 3 Odanacatib 10 mg/Odanacatib 50 Mg-Ext 2
n=17 participants at risk
During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
|
Year 3 Odanacatib 25 mg/Placebo-Ext 2
n=19 participants at risk
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Year 3 Odanacatib 25 mg/Odanacatib 50 Mg-Ext 2
n=21 participants at risk
During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
|
Year 3 Odanacatib 50 mg/Placebo-Ext 2
n=18 participants at risk
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Year 3 Odanacatib 50 mg/Odanacatib 50 Mg-Ext 2
n=20 participants at risk
During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
|
Years 4-5 Combined Group A.1: Odanacatib 50 mg
n=73 participants at risk
Combined Group A.1 consists of participants who received odanacatib 50 mg once a week during Year 3.
During this 24-month extension (Years 4-5), these participants continued to receive odanacatib 50 mg once a week.
|
Years 4-5 Combined Group A.2: Odanacatib 50 mg
n=27 participants at risk
Combined Group A.2 consists of participants who received placebo or odanacatib 3 mg in Years 1, 2 and 3. During this 24-month extension (Years 4-5), these participants received odanacatib 50 mg once a week.
|
Years 4-5 Combined Group A.3: Placebo
n=41 participants at risk
Combined Group A.3 consists of participants who, during this 24-month extension (Years 4-5), received placebo once a week.
|
Years 6-10 Group A: Odanacatib 50 mg Once Weekly
n=28 participants at risk
Group A consists of a combination of participants who were treated with odanacatib 25 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 50 mg for 10 years.
|
Years 6-10 Group B: Odanacatib 50 mg Once Weekly
n=34 participants at risk
Group B consists of a combination participants who were treated with placebo for 2 years, then odanacatib 50 mg for 8 years; participants who were treated with odanacatib 3 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 10 mg for 2 years, then odanacatib 50 mg for 8 years.
|
Years 6-10 Group C: Odanacatib 50 mg Once Weekly
n=23 participants at risk
Group C consists of a combination of participants who were treated with placebo for 3 years, then odanacatib 50 mg for 7 years; and participants who were treated with odanacatib 3 mg for 2 years, then placebo for 1 year, then odanacatib 50 mg for 7 years
|
Years 6-10 Group D: Odanacatib 50 mg Once Weekly
n=32 participants at risk
Group D consists of a combination of participants who were treated with odanacatib 10 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; participants who were treated with odanacatib 25 mg for 5 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; and participants who were treated with odanacatib 50 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
3.6%
3/83 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.8%
8/82 • Number of events 8 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.8%
6/77 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/79 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.1%
3/73 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.1%
2/28 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
2/34 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.4%
7/83 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
4/82 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.4%
8/77 • Number of events 8 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/79 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.0%
7/78 • Number of events 10 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.1%
2/22 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
15.0%
3/20 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.1%
3/27 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.1%
2/28 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
2/34 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
17.4%
4/23 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.2%
2/32 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Otitis Media Acute
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's Contracture
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Eye disorders
Macular Degeneration
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.4%
5/78 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Eye disorders
Cataract
|
2.4%
2/83 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.2%
4/77 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.5%
2/19 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.4%
2/27 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.3%
3/41 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
17.6%
6/34 • Number of events 9 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
26.1%
6/23 • Number of events 10 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.4%
2/83 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.1%
5/82 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.5%
5/77 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.4%
5/78 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.4%
2/27 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.4%
3/32 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
3.6%
3/83 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.1%
4/79 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.1%
2/18 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.4%
2/27 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.8%
4/83 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.9%
3/77 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/79 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.4%
5/78 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.1%
3/73 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
17.4%
4/23 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.4%
3/32 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
3/82 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.2%
4/77 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.3%
5/79 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/78 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.5%
2/19 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.1%
2/22 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.5%
2/21 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.1%
3/73 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.4%
2/27 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.7%
2/23 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.2%
2/32 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
9.6%
8/83 • Number of events 8 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
4/82 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.8%
6/77 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.6%
6/79 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.4%
5/78 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.4%
2/27 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Toothache
|
4.8%
4/83 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
3/82 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.2%
4/77 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.5%
4/73 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
General disorders
Fatigue
|
7.2%
6/83 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/78 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
General disorders
Influenza Like Illness
|
3.6%
3/83 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.9%
3/77 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.7%
6/78 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Bronchitis
|
2.4%
2/83 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
4/82 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.2%
4/77 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.1%
2/22 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.5%
4/73 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
14.8%
4/27 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.8%
4/41 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.7%
3/28 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
14.7%
5/34 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
21.7%
5/23 • Number of events 9 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
15.6%
5/32 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Cystitis
|
1.2%
1/83 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.3%
6/82 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.9%
3/77 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.0%
2/20 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.7%
2/23 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
4.8%
4/83 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.2%
4/77 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.5%
2/19 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Sinusitis
|
4.8%
4/83 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
4/82 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.5%
5/77 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.1%
4/79 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.4%
5/78 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.1%
2/18 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.1%
3/73 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.1%
3/27 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
2/41 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
17.4%
4/23 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.8%
9/83 • Number of events 11 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
12.2%
10/82 • Number of events 12 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.1%
7/77 • Number of events 9 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.9%
7/79 • Number of events 11 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
12.8%
10/78 • Number of events 14 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
16.7%
3/18 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.8%
2/17 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.5%
2/21 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.1%
3/73 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.1%
2/28 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.8%
3/34 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.7%
2/23 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.2%
2/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Urinary Tract Infection
|
13.3%
11/83 • Number of events 17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.3%
6/82 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.1%
7/77 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.1%
8/79 • Number of events 10 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
15.4%
12/78 • Number of events 15 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.1%
2/22 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.8%
2/17 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
14.3%
3/21 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.0%
2/20 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
13.7%
10/73 • Number of events 12 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
14.8%
4/27 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
2/41 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
32.1%
9/28 • Number of events 15 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
26.5%
9/34 • Number of events 19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
26.1%
6/23 • Number of events 20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
21.9%
7/32 • Number of events 15 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.0%
5/83 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.5%
5/77 • Number of events 8 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/78 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.5%
4/73 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
2/41 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.7%
3/28 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.4%
3/32 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Investigations
Alanine Aminotransferase Increased
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
3/82 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.3%
5/79 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
17.4%
4/23 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.4%
3/32 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
8.4%
7/83 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
3/82 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.2%
4/77 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/79 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.7%
6/78 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
2/41 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.1%
2/28 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Investigations
Aspartate Aminotransferase Increased
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
3/82 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.1%
4/79 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
17.4%
4/23 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.2%
2/32 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Investigations
Weight Decreased
|
2.4%
2/83 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.1%
4/78 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
2/34 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.7%
2/23 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.2%
2/32 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Investigations
Weight Increased
|
4.8%
4/83 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.9%
3/77 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.3%
5/79 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/78 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.7%
13/83 • Number of events 24 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
14.6%
12/82 • Number of events 16 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
15.6%
12/77 • Number of events 13 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
17.7%
14/79 • Number of events 17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
15.4%
12/78 • Number of events 14 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
15.8%
3/19 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.5%
2/19 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
14.3%
3/21 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
15.0%
3/20 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
12.3%
9/73 • Number of events 13 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
14.8%
4/27 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
14.6%
6/41 • Number of events 8 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
17.9%
5/28 • Number of events 10 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.8%
4/34 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
34.8%
8/23 • Number of events 8 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.4%
3/32 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
4.8%
4/83 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.5%
7/82 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.1%
7/77 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/79 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
16.7%
13/78 • Number of events 16 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.1%
2/22 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.0%
2/20 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.1%
3/73 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.7%
2/23 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
6.0%
5/83 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
3/82 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.5%
5/77 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
12.7%
10/79 • Number of events 11 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.1%
4/78 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.5%
2/19 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
14.3%
3/21 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.1%
2/18 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.5%
4/73 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
14.6%
6/41 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.7%
3/28 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.8%
4/34 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
21.7%
5/23 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
12.5%
4/32 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.6%
3/83 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.2%
4/77 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/79 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
2/34 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.7%
2/23 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
3.6%
3/83 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.3%
5/79 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.5%
2/21 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
20.0%
4/20 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.1%
3/73 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.4%
2/27 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.8%
3/34 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
13.0%
3/23 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.4%
2/83 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.1%
5/82 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.2%
4/77 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.1%
4/79 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.4%
5/78 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.1%
2/18 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
14.3%
3/21 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.2%
6/73 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.4%
2/27 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.7%
3/28 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
14.7%
5/34 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.7%
2/23 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.2%
2/32 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.3%
6/82 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.1%
2/28 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.8%
3/34 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.7%
2/23 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.2%
2/32 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
4.8%
4/83 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.5%
7/82 • Number of events 9 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.4%
8/77 • Number of events 10 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/79 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.1%
4/78 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.1%
2/18 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.1%
2/28 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.8%
3/34 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.7%
2/23 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.2%
2/32 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
13.3%
11/83 • Number of events 13 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.0%
9/82 • Number of events 9 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
13.0%
10/77 • Number of events 10 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.4%
9/79 • Number of events 10 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.5%
9/78 • Number of events 12 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.1%
2/22 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
17.6%
3/17 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.4%
2/27 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
2/34 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
13.0%
3/23 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.4%
3/32 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Psychiatric disorders
Depression
|
6.0%
5/83 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
4/82 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.5%
5/77 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/79 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/78 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.1%
2/22 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.1%
3/27 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.7%
3/28 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.8%
4/34 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.7%
2/23 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.2%
2/32 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
2.4%
2/83 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
3/82 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.9%
3/77 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.3%
5/79 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.1%
3/73 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
2/41 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.4%
7/83 • Number of events 10 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
4/82 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.5%
5/77 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/78 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.5%
2/19 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.1%
2/18 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
2/34 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.7%
2/23 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
4.8%
4/83 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.5%
7/82 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.9%
3/77 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.1%
8/79 • Number of events 8 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.1%
4/78 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.5%
2/19 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.1%
2/18 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.8%
5/73 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.4%
2/27 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
2/41 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.7%
3/28 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
17.6%
6/34 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
21.7%
5/23 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.4%
3/32 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Cardiac disorders
Mitral Valve Prolapse
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.4%
2/83 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
2/34 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.7%
2/23 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Ear and labyrinth disorders
Tympanosclerosis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
4.8%
4/83 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.9%
3/77 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/78 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.1%
2/18 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
14.7%
5/34 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.9%
3/77 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.1%
4/79 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Endocrine disorders
Thyroiditis Chronic
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Eye disorders
Conjunctivitis Allergic
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.8%
2/17 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.5%
2/21 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
2/41 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.2%
2/32 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Anal Fissure
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Faecal Incontinence
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastric Disorder
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastric Polyps
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
3/82 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.0%
2/20 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
2/34 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Gingival Swelling
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.9%
3/77 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.8%
3/34 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
General disorders
Calcinosis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
General disorders
Chest Discomfort
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
General disorders
Chest Pain
|
4.8%
4/83 • Number of events 8 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/78 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.5%
2/19 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.1%
2/28 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
General disorders
Oedema Peripheral
|
3.6%
3/83 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
15.0%
3/20 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
2/34 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.7%
2/23 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Immune system disorders
Allergy To Arthropod Sting
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Cellulitis
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Chronic Sinusitis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
2/34 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Eye Infection
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.2%
2/32 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Fungal Infection
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Furuncle
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Herpes Zoster
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
2/34 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
3/82 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/78 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.5%
2/21 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.5%
4/73 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.8%
4/34 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
15.6%
5/32 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Nasal Abscess
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
16.9%
14/83 • Number of events 20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.0%
9/82 • Number of events 13 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
20.8%
16/77 • Number of events 20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.1%
8/79 • Number of events 10 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
17.9%
14/78 • Number of events 23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
18.2%
4/22 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.1%
2/18 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.8%
2/17 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
16.7%
3/18 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.5%
2/19 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
14.3%
3/21 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
17.8%
13/73 • Number of events 16 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
22.2%
6/27 • Number of events 13 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
24.4%
10/41 • Number of events 13 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
25.0%
7/28 • Number of events 9 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
23.5%
8/34 • Number of events 15 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
21.7%
5/23 • Number of events 9 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
28.1%
9/32 • Number of events 20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
2/34 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
13.0%
3/23 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Oral Herpes
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.1%
2/28 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
2/41 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.4%
3/32 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Pyoderma
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Rhinitis
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
3/82 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.1%
2/28 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Tooth Abscess
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/78 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/79 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Viral Infection
|
1.2%
1/83 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.1%
4/79 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
1.2%
1/83 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
3/82 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.1%
2/28 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
2/83 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.1%
2/18 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.1%
3/73 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
2/41 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.7%
3/28 • Number of events 13 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.8%
4/34 • Number of events 8 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
21.7%
5/23 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
12.5%
4/32 • Number of events 9 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
4.8%
4/83 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/79 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/78 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.1%
2/22 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.1%
4/79 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
2/41 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.4%
2/27 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.1%
2/22 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Skull Fractured Base
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
2.4%
2/83 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Investigations
Blood 1,25-Dihydroxycholecalciferol Increased
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Investigations
Blood Cholesterol Increased
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.8%
2/17 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Investigations
Blood Parathyroid Hormone Increased
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.8%
5/73 • Number of events 13 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.1%
3/27 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
2/41 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.5%
2/21 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Investigations
Blood Triglycerides Increased
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
2/41 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Investigations
Carotid Bruit
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Investigations
Glucose Urine Present
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Investigations
High Density Lipoprotein Decreased
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Investigations
Lymphocyte Count Decreased
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
16.7%
3/18 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Investigations
White Blood Cells Urine Positive
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
3/82 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/79 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.1%
2/18 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.4%
2/27 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.7%
3/28 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
12.5%
4/32 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.0%
10/83 • Number of events 12 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
20.7%
17/82 • Number of events 19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.7%
9/77 • Number of events 11 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
17.7%
14/79 • Number of events 19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
14.1%
11/78 • Number of events 13 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.5%
2/19 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
22.7%
5/22 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.8%
2/17 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
21.1%
4/19 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.5%
2/21 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.0%
8/73 • Number of events 11 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
18.5%
5/27 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
21.4%
6/28 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
20.6%
7/34 • Number of events 9 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
21.7%
5/23 • Number of events 7 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.2%
2/32 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
2.4%
2/83 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.9%
3/77 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/79 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/78 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.8%
2/17 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.4%
2/27 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
6.2%
2/32 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.1%
2/18 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle Contracture
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
2/34 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/79 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.4%
3/32 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteochondritis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteosclerosis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
12.0%
10/83 • Number of events 13 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.8%
8/82 • Number of events 10 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.4%
8/77 • Number of events 8 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
13.9%
11/79 • Number of events 11 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/78 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
13.6%
3/22 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.8%
2/17 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
16.7%
3/18 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
15.8%
3/19 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.5%
2/21 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
16.4%
12/73 • Number of events 15 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
14.8%
4/27 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
2/41 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
21.4%
6/28 • Number of events 6 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.7%
2/23 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
21.9%
7/32 • Number of events 9 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.9%
3/77 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Neoplasm
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Migraine
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Paraesthesia
|
2.4%
2/83 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.1%
3/73 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
2/41 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
2/34 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Sciatica
|
2.4%
2/83 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Somnolence
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Tension Headache
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Tremor
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.8%
2/17 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Nervous system disorders
Trigeminal Neuralgia
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.9%
3/77 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
10.5%
2/19 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Psychiatric disorders
Dysthymic Disorder
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Psychiatric disorders
Stress
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Reproductive system and breast disorders
Breast Mass
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Reproductive system and breast disorders
Fibrocystic Breast Disease
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Reproductive system and breast disorders
Vulvovaginal Discomfort
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
2/83 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
2/82 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 5 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/79 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.8%
3/78 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
11.8%
2/17 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.5%
4/73 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.3%
3/41 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
2/34 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.8%
3/34 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/78 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.2%
1/83 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
2/34 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
9.4%
3/32 • Number of events 4 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
8.7%
2/23 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Granuloma Annulare
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.6%
1/28 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Lichen Planus
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.6%
2/77 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
7.1%
2/28 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.2%
1/83 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Sebaceous Hyperplasia
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
1.2%
1/83 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.9%
3/77 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.7%
1/27 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.5%
2/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.5%
1/22 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.4%
1/41 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.9%
1/34 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Vascular disorders
Flushing
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Vascular disorders
Haematoma
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.2%
1/82 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.8%
1/21 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
2.7%
2/73 • Number of events 3 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.6%
1/18 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/23 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Vascular disorders
Varicose Vein
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.3%
1/79 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
1.4%
1/73 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.9%
2/41 • Number of events 2 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
3.1%
1/32 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
|
Eye disorders
Eyelid Ptosis
|
0.00%
0/83 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/82 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/77 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/79 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/78 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/22 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
5.9%
1/17 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/17 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/19 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/21 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/18 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/20 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/73 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/27 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/41 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/28 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/34 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
4.3%
1/23 • Number of events 1 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
0.00%
0/32 • Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER